Candidates must hold a Bachelor's degree in a technical field and possess at least 5 years of direct experience in medical device, drug, or biologic regulatory roles. Proven expertise in FDA interactions, quality management systems, and international regulatory standards is required.

DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this high visibility role will have a significant and direct impact on the success of the innovative life science devices that DEKA develops. The person in this role will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as international approvals including CE Marking.

How you will make a difference as a Regulatory Project Manager: 
Work in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers
Provide leadership and guidance to R&D in developing successful regulatory strategies across the entire product life cycle
Mentor regulatory affairs staff, as well as internal cross-functional partners, on effective regulatory strategies and tactics
Lead FDA interactions including in-person meetings, teleconferences, written submissions and other Agency engagements as needed
Participate in the design and conduct of clinical trials, and assist in obtaining and maintaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance
Skills you will need to be successful: 
BS in a technically related field
Minimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
Experience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and participation in face-to-face meetings
Strong written and verbal communication skills
Demonstrated ability to continually balance priorities in a dynamic and fast-paced environment
Expertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR’s and Field Action Reporting
Experience in Medical Device Quality Regulations including Quality Management Systems Regulations (QMSRs), ISO 13485, and MDSAP
Demonstrated ability in expanding regulatory organization capabilities
Experience with drug, biologic and combination product approvals a plus
RAC certification a plus
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

Regulatory Affairs Project Manager

Candidates must possess a Bachelor's degree in public policy or a related field, with a Master's degree considered a plus. A minimum of 8-10 years of experience in federal regulatory issues, particularly within the food and nutrition sector, is required.

Position Summary
Are you interested in making an impact on the Food and Nutrition Industry? Kellen is an association management firm seeking an experienced professional to serve as a Director of Regulatory Affairs to support clients in the food industry. A successful candidate will be a key contributor to the Public Affairs team, developing and executing strategies to achieve client objectives with a deep knowledge of the complex regulatory landscape. They will maintain effective liaison with designated federal agencies, non-governmental organizations, and relevant coalitions involved in issue-related programs. Interested candidates should have a strong understanding of the food industry regarding regulatory processes as this individual will play a crucial role in representing client priorities and ensuring that client policies and positions are effectively communicated to government officials and other relevant stakeholders.

Key responsibilities include:
· Serving as the regulatory lead for multiple associations in the food industry, overseeing day-to-day execution of the policy agenda, offering strategic guidance on association priorities.
· Monitoring, evaluating, interpreting, and summarizing complex regulatory information related to food products of interest to clients.
· Communicating directly with clients and key stakeholders, including regulators and policymakers, on critical issues impacting clients.
Essential Functions
Lead execution of priorities for regulatory committees and working groups for multiple food association clients representing industry food categories and/or ingredients as well as packaging. This role includes the development of strategic action plans, addressing specific industry issues, and collaborating with internal teams and client members to achieve objectives.
Specific responsibilities include, but are not limited to:
Manage regulatory and government affairs issue scope, including development of client materials in relation to activity from federal agencies (e.g., regulatory comments).
Develop accurate comment letters influencing policies based on analysis of current and proposed regulations, ensuring comments are incorporated into policies. Engage policymakers to clarify or refine client comments, as needed.
Provide input on strategy for client activities and priorities to respond to dynamic policy environment.
Identify and analyze emerging issues in federal and state food and nutrition policy, including priority client objectives and their alignment with Administration and state legislature interests.
Manage relationships with policymakers and key stakeholders, including appropriate Administration officials and professional organizations to promote regulatory agenda and execute strategic objectives.
Prepare materials for clients to be utilized in official meetings. Brief stakeholders, client leadership, and government affairs colleagues on priorities for federal advocacy.
Attend meetings with federal agency staff, public policy or congressional hearings, briefings, coalition meetings, and other events to represent association clients and develop or circulate reports.
Identify and analyze emerging issues in proposed federal and state policy, including priority client advocacy objectives.
Build relationships with external organizations including identifying potential stakeholders or organizing conference participants and speakers.
Communicate frequently with clients and internal team to meet deadlines and recommend actions, as needed.
Lead multiple client regulatory committees, workgroups, and workstreams to direct progress for strategic priorities.
Other duties that align with the mission and vision of the company, as assigned.
Qualifications
Bachelor’s degree or higher in a discipline related to public policy or a related field. Master’s degree a plus.
8-10 years experience working in Congress, federal agencies, consulting firms, trade associations, or specialty societies on federal regulatory issues, including experience with food and nutrition issues.
Strong expertise regarding federal regulatory policy is a must. Deep understanding of current domestic affairs and their political implications is also preferred. Knowledge of state regulatory and policy activity a plus.
Food industry experience is a plus.
Excellent interpersonal skills crucial for success, including relationship building and maintenance skills, demonstrating ability to act as a positive team player.
Strong analytical and organizational skills with attention to detail. A proven self-starter with the ability to direct and manage projects is ideal.
Excellent verbal and written communication skills, including strong presentation skills, which will aid in a multi-task oriented work environment.
Computer experience including Microsoft Word, Excel, PowerPoint, and Teams, with a “Can Do” approach to diverse software packages.
Willingness to travel.
Physical Demands
This job can be located in Washington, D.C or Chicago, IL. Kellen operates in a hybrid working environment (i.e., working both in the office every Tuesday and Wednesday and remotely other days of the week). The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· This role routinely uses standard office equipment such as computers and telephones. The ability to perform computer work for eight or more hours a day in an office setting is required.
· This is largely a sedentary role; however, some travel is required, and this would require the ability to lift, bend, or stand as necessary. This position requires frequent verbal, written, and interpersonal communication skills.
· Must be able to lift, move, and manipulate up to 30 pounds.
Travel Requirements
Travel is an essential duty of the position, up to 15% of the time.
Kellen EEO Statement
Kellen does not discriminate against any employee or applicant on the basis of age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. We adhere to these principles in all aspects of employment, including recruitment, hiring, training, compensation, promotion, benefits, social and recreational programs, and discipline. In addition, it is the policy of Kellen to provide reasonable accommodation to qualified employees who have protected disabilities to the extent required by applicable laws, regulations and ordinances where a particular employee works.

Director, Regulatory Affairs

Candidates must have at least 5 years of regulatory affairs experience within an industry-related environment. A minimum of a Bachelor’s degree in a scientific or technical discipline is required, with a preference for advanced degrees.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are seeking a highly organized and collaborative Regulatory Affairs Generalist to support a strategic pharmaceutical partnership and its associated development and commercial programs. This role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements. The ideal candidate thrives in a dynamic, cross‑company environment, effectively balances multiple priorities, and brings strong communication, problem‑solving, and collaboration skills to support successful partnership outcomes. The Regulatory Affairs Generalist provides comprehensive support across clinical, submission, and post approval regulatory activities for assigned pharmaceutical products and development programs. This role works cross functionally to ensure operational excellence in regulatory planning, documentation management, submission execution, and compliance with global regulatory requirements. The ideal candidate thrives in a dynamic environment, is highly organized, and demonstrates strong communication and problem-solving skills. Key Responsibilities 1. Regulatory Archiving & Documentation Management Maintain U.S. regulatory archive logs, including: Recording new submissions. Archiving regulatory authority correspondence. Upload and manage correspondence from global partners for assigned programs. Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools. Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations. 2. Clinical Regulatory Support Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation. Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support IND level compliance. Author 1572 waiver requests and support routine regulatory submissions for clinical investigators. Attend cross functional clinical trial team meetings as the Regulatory Affairs representative, providing regulatory interpretation, updates, and risk assessments. 3. Regulatory Submission Preparation Draft administrative components of regulatory submissions, including: FDA forms Cover letters Submission metadata and other supporting documents Build and organize electronic submission structures using RIM systems or industry standard submission planning tools. Manage internal workflows and approval processes to ensure timely completion of submission components. Coordinate submission package delivery through established publishing workflows and oversee communication with submission/publishing teams. 4. Global Regulatory Team (GRT) & Cross Functional Collaboration Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings, governance discussions, and alliance meetings. Serve as the Regulatory Affairs representative in partner or alliance meetings for assigned products, providing updates and tracking action items. Support ongoing cross functional program meetings as needed, ensuring regulatory deliverables and timelines remain on track. 5. Authoring & Reviewing Regulatory Submissions Contribute to the drafting, review, and preparation of regulatory submissions across development phases, including: FDA meeting requests Briefing documents Applications for special regulatory designations (e.g., Fast Track, Orphan Drug Designation) IND submissions, amendments, and associated documentation Ensure content is scientifically sound, consistent, clear, and aligned with regulatory standards and internal templates. 6. Post Approval Regulatory Maintenance Prepare, review, and submit periodic post marketing regulatory reports for assigned products, including: PADERs (Periodic Adverse Drug Experience Reports) NDA Annual Reports DSURs (Development Safety Update Reports) PBRERs (Periodic Benefit Risk Evaluation Reports) Maintain tracking and compliance with global post approval commitments, submission deadlines, and regulatory requirements. Support lifecycle management activities to ensure continued product compliance. Skills: Project management knowledge Client-focused approach to work Results orientation Teamwork and collaboration skills Consulting skills Excellent interpersonal and intercultural communication skills, both written and verbal Critical thinking and problem-solving skills Proficiency in local language and extensive working knowledge of the English language Knowledge and Experience: 5+ years of related regulatory affairs experience in an industry-related environment Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred. Other: Due to the client’s location, candidates located in the Eastern or Central time zones of the US or Canada are preferred. The ability to travel up to 20% may be required. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Regulatory Affairs Consultant - Regulatory Generalist

Candidates must possess a bachelor's degree in a relevant field and at least 5 years of experience in public policy, health policy, or regulatory compliance. Strong analytical and writing skills are required, with a master's degree and healthcare policy experience considered preferred qualifications.

Building Location: Building D - Miller Dwan Medical Center - EH Duluth Department: 1008260 OFFICE OF CEO - EH SS Job Description: As a member of the Public Policy team, the Regulatory Affairs Program Manager will play an essential role in leading program and operations management for regulatory affairs. The program manager will support the public policy lifecycle by identifying, tracking, analyzing, and responding to state and federal regulatory public policy issues across the organization. This position is responsible for maintaining operations of the regulatory affairs program, including key performance indicators while collaborating with subject matter experts across the organization to identify, analyze and influence state and federal regulatory public policy issues that impact care delivery in alignment with key business strategies and mission. Education Qualifications: Key Responsibilities: Regulatory Affairs Program and Operations Management Serve as the primary program manager for regulatory affairs Assist with developing, implementing, and tracking key performance indicators for regulatory affairs Assist in developing organizational public policy priorities Advocate for regulatory public policy issues in the interests of the organization Track, analyze, and communicate regulatory public policy issues Support the public policy lifecycle with monitoring, identifying, and analyzing state and federal proposed regulations that impact the organization, our patients, and communities Convene internal content experts regularly to solicit input on key regulatory public policy issues Participate in educational opportunities pertaining to regulatory issues Compose regulatory public comment letters using sound judgement and political acumen Lead the development of internal regulatory affairs communication products Prepare and deliver presentations, participate, and facilitate meetings using remote technology including Microsoft Teams Support legislative and regulatory implementation projects Database Management Serve as primary database manager for regulatory public policy information Develop document filing logic and nomenclature using software tools, as necessary Compose and manage regulatory summaries, analyses, text, presentations, and other supporting documentation in a centralized repository Committee, coalition, and project administration Provide staffing support for internal regulatory affairs committee Participate on various internal and external committees Serve and participate on external coalitions as needed to support and advance regulatory public policy issue priorities Other duties as assigned. Educational Requirements: Bachelor's degree in Public Policy, Public Administration, Political Science, Health Policy, Health Management, Health Information Management, or other health care related field Required Qualifications: 5 years’ experience public policy, public affairs, government, health policy, compliance, regulatory, accreditation, or audit Strong analytical and writing skills Preferred Qualifications: Master’s Degree in related field Experience with health care policy Licensure/Certification Qualifications: FTE: 1 Possible Remote/Hybrid Option: Remote Shift Rotation: Day/Eve/Night Rotation (United States of America) Shift Start Time: Shift End Time: Weekends: Holidays: No Call Obligation: No Union: Union Posting Deadline: Compensation Range: $84,364.80 - $126,547.20 Employee Benefits at Essentia Health: At Essentia Health, we’re committed to supporting your well-being, growth, and work-life balance. Our comprehensive benefits include medical, dental, vision, life, and disability insurance, along with supplemental options to fit your needs. We offer a 401(k) plan with employer contributions to help you plan for the future, and we invest in your professional development through training, tuition reimbursement, and educational programs. To help you thrive both at work and at home, we provide flexible scheduling, generous time off, and wellness resources focused on your physical, mental, and emotional health. Please note that benefit eligibility may vary. For full details, refer to your benefit summary or contact our HR Service Center at (218) 576-0000. To search for more jobs, please CLICK HERE. Find more than a job. Find more in yourself. Find your calling. Essentia Health seeks employees who embrace our commitment to patient- and family-centered care in communities both large and small. We're looking for people who are committed to making patients and their families feel known and understood. People who understand what it means to be Here with you. People who are willing to use their strengths to help others. Our Values Quality | Hospitality | Respect | Joy | Justice | Stewardship | Teamwork Essentia Health is an Equal Opportunity/Affirmative Action Employer. Essentia Health does not discriminate in employment because of age, color, creed, culture, disability (physical or mental), ethnicity, familial status, gender identity or expression, genetic information, language, local Human Rights Commission activity, national origin, military service, race, religion, sex, sexual orientation, socioeconomic status, or public assistance status. Job offers are contingent upon successful completion of post-offer screenings. Screenings includes verification of your legal right to work in the United States, a health screening and immunization review, verification of applicable licensure, certifications, education, and experience, and background checks including criminal, urine drug screen and MVR where required.

Program Manager - Regulatory Affairs

Candidates must have a bachelor's degree in science or engineering and at least 4 years of regulatory, quality, or compliance experience in medical devices or biologics. Proficiency in regulatory intelligence tools, strong analytical skills, and experience with FDA or EU device regulations are required.

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device
company focused on developing simple, elegant solutions that address cardiac and
vascular surgeons’ most difficult challenges in treating patients with aortic
diseases. Artivion’s four major groups of products include: aortic stent grafts,
surgical sealants, On-X mechanical heart valves, and implantable cardiac and
vascular human tissues. Artivion has over 1,400 employees worldwide with sales
representation in over 100 countries. The Company has manufacturing facilities
located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally,
it has sales and distribution offices in various countries throughout Europe,
Asia, and South America. For additional information about Artivion, visit our
website, www.artivion.com [http://www.artivion.com/].

Position Overview:

The Sr. Project Manager, Global Regulatory Intelligence will monitor, gather,
and analyze global regulatory changes and trends to provide insights that ensure
compliance and support strategic decision-making for the global regulatory
organization. The role is a key partner in ensuring regulatory compliance across
the organization with existing and changing regulation.

Key duties include tracking regulations and standards, triaging the changes for
assessment and tasks, assessing impact on business operations, advising internal
teams on compliance, and helping to develop regulatory strategies. The role will
also support process improvements, internal reporting and advance system
capabilities. In collaboration with senior RA Management, the role will work
directly with industry organizations, regulatory bodies and external services to
monitor regulations/standards and support compliance for Artivion product and
processes. The individual has department and cross-functional influence and is
generally recognized as an expert resource within the department. This role will
collaborate with global Artivion stakeholders (e.g. R&D, Quality, Clinical,
Operations) as subject matter expert and will mentor junior staff, as
appropriate.

Responsibilities:

 * The role will track, monitor, analyze, and interpret global regulatory
   developments (regulations, guidelines, standards and legislation) to ensure
   compliance and strategic decision-making within the organization.
 * Proactively identify, mitigate, and manage potential regulatory or compliance
   risks by staying ahead of upcoming changes and initiatives. Communicate new
   and upcoming changes. Facilitate and assist with interpretation to guide
   product and business compliance with regulatory requirements.
 * The role will assess impact to business operations and provide insights to
   functions and teams. Provide actionable insights to internal stakeholders.
   Drive internal review and implementation with Subject Matter Experts. Ensure
   projects and tasks meet business objectives and expectations.
 * Manage and utilize regulatory intelligence tools, databases, and other
   information resources to maintain a knowledge base and improve processes.
 * Maintain expert proficiency in worldwide regulatory requirements; establish
   and maintain advanced relationships with agency personnel and industry
   organizations. Collaborate with functional partners to implement regulatory
   changes to regulatory/compliance documentation and procedures. Drive issues
   to resolution.
 * Act as a Regulatory Subject Matter Expert (SME) on key topics and provide
   strategic guidance to regulatory affairs, functions, and cross-functional
   teams. Collaborate with quality, clinical, legal, and operations to align
   regulatory intelligence strategies.
 * Influences management on technical or business solutions related to
   regulatory intelligence. Develop network of internal partners and be a
   subject matter expert to ensure projects meet regulatory requirements.
 * Establish and maintain positive relationships with stakeholders and team
   members. Leverage experience and technical knowledge to advance corporate
   strategies.
 * Examine and recommend opportunities within industry to advance organizational
   objectives.
 * This position requires strong collaboration, communication, and analytical
   skills to support product development, market access, and post-market
   activities in alignment with global regulatory requirements.
 * The role involves using regulatory databases and specialized software. Train
   others in the use of regulatory systems and tools. Advise on process
   improvements and lead to completion, where assigned. Drive to solutions.
 * Communicate complex regulatory information clearly and concisely to various
   internal teams, such as product development, research, operations, and
   quality.
 * Lead complex technical projects with considerable initiative and
   independence, strategic and critical thinking, and effective decision-making
   skills, with the ability to prioritize and balance multiple competing
   priorities and escalate issues when critical risks arise. Advanced project
   management skills applied to all assignments.
 * May support regulatory submissions. Track and report the status of regulatory
   actions and submissions to internal stakeholders.
 * Participate in inspections, audits, and post-audit corrective actions.
 * Ensure understanding of all quality policy/system items, as applicable.
   Maintain and update regulatory processes and SOPs. Follow all work/quality
   procedures to ensure quality system compliance. Support general quality
   system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management,
   etc.).

Qualifications: 

Required: 

 * Bachelor's degree in science, engineering or related field, with a minimum of
   4 years of regulatory, quality, and/or compliance experience in medical
   device or biologics.
 * Experience with FDA Class II or III devices or experience with EU Class
   IIa/IIb or III devices.
 * Experience with interpretation and application of new regulations,
   legislation, standards or guidelines.
 * Strong analytical, technical writing, communication, organizational, project
   management, time management and interpersonal relationship skills.
 * Awareness of global regulatory affairs, product development and total product
   lifecycle processes.
 * Strong ability to sift through complex information, discern high-quality
   data, and translate it into meaningful intelligence.
 * Excellent verbal and written communication skills are essential for conveying
   complex regulatory topics to diverse internal audiences.
 * Proficiency with regulatory intelligence databases and monitoring tools, and
   general office software.
 * Strong attention to detail for accurately tracking and interpreting
   regulatory information.
 * Experience working with cross-functional teams.
 * Ability to comprehend principles of engineering, physiology, and medical
   device use.
 * Ability to effectively manage and prioritize numerous projects and
   responsibilities.
 * Strong analytical, technical writing, verbal/written communication,
   organizational, and time management skills.
 * Must be flexible, able to adapt easily, and willing to take initiative and
   lead regulatory projects.
 * Project management experience.
 * Ability to effectively manage and prioritize numerous projects in a
   fast-paced environment.
 * Expertise in Microsoft Office Suite

 Preferred:

 * Experience with US FDA, Notified Body interaction, and Health Canada Class 3
   or 4 devices, international submissions, cardiovascular devices and/or human
   tissue preferred.
 * Ability to apply experience to ensure regulatory affairs compliance and cross
   functional interaction

Global Regulatory Intelligence, Senior Project Manager

Candidates must hold a Bachelor's degree in Life Sciences and possess 1-3 years of experience in pharmaceutical or medical device Regulatory Affairs. Strong communication skills and the ability to work effectively within cross-functional teams are essential.

Job Title: Manager Regulatory Affairs Location: Morristown, NJ Cambridge, MA About the Job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities: Identifies product specific or therapeutic area A&P issues and works with other teams to propose and implement solutions. Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters. Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision. Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively. Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs. Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications. Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders. Performs other duties as assigned. About You Basic Qualifications: Bachelor’s degree in Life Sciences from an accredited four-year college or university. Work Experience Required: 1-3 Years experience in the following areas: Experience within pharmaceutical or medical device Regulatory Affairs. Successful track record with ideally 1-3 years relevant regulatory experience. Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc. Knowledge, Skills and Equivalent Experience: Knowledge and understanding of complex medical and scientific subject matter. Ability to work well within cross-functional teams. Demonstrates solid oral communication and writing skills. Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology. Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution. Develops collaborative relationships to facilitate the accomplishment of work goals. Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities. Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans. Can build collaborative internal networks to obtain cooperation. Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values. Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed. Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well. Deals with people in an honest and forthright manner representing information and data accurately. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $122,250.00 - $176,583.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

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