Candidates should have a high school diploma or equivalent, with a preference for a degree in life sciences, business, or a related field. Experience in regulatory affairs or regulatory filing, preferably in health insurance, is also required.

Position Overview:

The Project Manager is responsible for serving Lumelight clients and partners, managing timelines, obtaining, and coordinating resources. Project Managers also ensure client deliverables meet quality standards starting with a project’s kick-off through completion. This position is client-facing while also working closely with the rest of the Client Delivery Team and other departments to ensure that everything we do is for the betterment of our clients. 

We are seeking a Healthcare Project Manager to oversee the planning and execution of various projects within our healthcare organization. Healthcare Project Manager responsibilities include initiating and managing projects, coordinating with different departments, setting project schedules, and ensuring the compliance of all projects with industry regulations and standards. Ideal candidates should have a deep understanding of the healthcare sector, project management expertise, and the ability to lead multidisciplinary teams.

Responsibilities

• Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders 

• Develop full-scale project plans and associated communications documents • Identify and manage project dependencies and critical path 

• Plan and schedule project timelines and milestones using appropriate tools 

• Develop and deliver progress reports, proposals, requirements documentation, and presentations 

• Ensure that projects are completed on time, within scope, and within budget 

• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques 

• Communicate project expectations to team members and stakeholders 

Education and Experience


• High school diploma or equivalent; degree in life sciences, business, or a related field is a plus, or bachelor’s degree in life sciences, business, or a related field. 

• 0-5 years of experience in regulatory affairs or regulatory filing, preferably in health insurance. 

Requirements

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and experience with regulatory submission software. 

• Strong written and verbal communication skills, with the ability to convey complex information clearly and effectively. 

• Proven ability to work collaboratively in a team environment and interact with cross functional teams. 

• Proven work experience as a Project Manager in the healthcare sector 

• Excellent knowledge of project management methodologies and tools 

• Strong understanding of the healthcare industry, including its regulations, procedures, and standards 

• Ability to manage multiple projects and tasks concurrently 

• Excellent communication and team management skills 

Work Environment: 

This position is a remote position within approved Lumelight states. This job operates in a professional office environment, whether in person or remotely. This role routinely uses standard office equipment such as computers, phones, and printers. Equipment will be provided to you.

Benefit Offerings:

 * Medical, Dental and Vision Benefits
 * Health Savings and Flexible Spending Account Options
 * 401(k) with Automatic Company Contribution
 * Employee Assistance Program
 * Company-paid Life and Disability Insurance 
 * Paid Time Off 

We are currently recruiting from the following states: Arizona (AZ), Florida (FL), Georgia (GA), Indiana (IN), Iowa (IA), Kentucky (KY), Louisiana (LA), Maryland (MD), Michigan (MI), Minnesota (MN), Missouri (MO), Montana (MT), Nebraska (NE), Nevada (NV), New Mexico (NM), North Carolina (NC), North Dakota (ND), Pennsylvania (PA), South Carolina (SC), South Dakota (SD), Tennessee (TN), Texas (TX), and Utah (UT).

Lumelight, LLC. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Regulatory Solutions Project Manager

Candidates must possess a Bachelor’s degree in a relevant science field (advanced degree preferred) and have 10 years of relevant experience working for a CRO or Pharmaceutical Company, including a minimum of 8 years in supervision. Thorough knowledge of ICH GCP guidelines, clinical trials, and the CRO industry relationship with biotech/pharma companies is essential.

Job Description: Director, Regulatory Affairs The Director, Regulatory Affairs leads and manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products, translating regulatory requirements into practical applications to ensure the success of clinical trials and regulatory submissions. S/he will serve on Veristat multidisciplinary project teams, provide independent regulatory strategy advice, advice on regulatory agency interactions, manage agency communications, lead the preparation of submissions, and create strong rapport with clients. The Director Regulatory Affairs acts as a point of escalation for challenging regulatory issues and serves as a mentor and project supervisor to more junior team members. The Director Regulatory Affairs will oversee the Regulatory aspects of projects and project teams through the management of internal staff and through interaction with Executive-level staff. They are responsible for the maintenance of optimal department processes, the implementation of project-specific strategies, and the development and implementation of department strategies to increase productivity and quality. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here! What we offer Benefits vary by location and may include: Remote working Flexible time off Paid holidays Medical insurance Tuition reimbursement Retirement plans What we look for Bachelor’s degree in science, toxicology, pharmacology, engineering or related field; Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials. 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company, with a minimum 8 years of supervisory experience required. Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required. In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff. Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment. Driving/Travel requirements – Travel up to 25% (Local & International) Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. #LI-RD1 Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives. We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen. We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace. Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices. Reasonable Accommodations Veristat is dedicated to providing an accessible and inclusive application experience for all candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at talentacquisition@veristat.com or +437 886 8063. We will work with you to meet your needs, ensuring a fair process. All requests in relation to your application will be treated confidentially. For more information about how we collect and store your personal data during the hiring process, please see our Career Recruitment Notice

Director, Regulatory Affairs

Candidates must possess a Bachelor's degree in business, legal, or a related field, along with 5+ years of healthcare experience and 3 years in project management from initiation through implementation. Certification in a project methodology or Agile practices is required, as is experience using project tracking tools.

Company
Navitus 
About Us
Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at https://employees-navitus.icims.com/ to be considered for internal opportunities. 
Pay Range
USD $87,954.00 - USD $107,920.00 /Yr. 
STAR Bonus % (At Risk Maximum)
5.00 - Salaried Non-Management except pharmacists 
Work Schedule Description (e.g. M-F 8am to 5pm)
M-F 8am to 5pm CT 
Remote Work Notification
ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. 
Overview
Due to growth, we are adding a Project Manager, Regulatory Implementation to our team!
The Project Manager, Regulatory Implementation is responsible for creating and executing project artifacts including project plans, communication plans, resource plans, and other tools used to guide teams in meeting project goals within defined scope and timelines. This role ensures the organization adheres to relevant laws, state regulations, and internal policies by assessing compliance risks, providing insightful guidance, and collaborating with various departments to develop and implement effective project plans. The Project Manager also ensures these plans are operational and transitions them to the appropriate departments for continued process improvements. 
Is this you? Find out more below! 
Responsibilities
How do I make an impact on my team? 
Lead and coordinate regulatory projects from initiation through completion, operationalizing requirements to meet state or federal standards and ensuring alignment with organizational goals. 
Schedule and facilitate project meetings to ensure progress and alignment with all stakeholders and taskforce while building strong relationships through proactive communication. 
Document key details, including meeting transcripts, action items, and assignments; share documentation with participants and ensure timely completion of action items. 
Maintain and update internal processes, leveraging tracking systems to monitor progress. 
Oversee cross-functional implementation of regulatory initiatives across multiple departments, managing timelines, resources, and deliverables.
Lead issue management by reporting issues and proposed solutions to impacted parties and driving them through to resolution.
Partner with Regulatory Auditor to develop processes for conducting compliance reviews and spot audits to monitor adherence to regulatory standards and identify areas for improvement.
Develop and manage project plans using project management tools, driving process redesign or improvements, and automation initiatives, may include assisting departments with creation of work instructions and forms. 
Prepare and present detailed analyses and reports, synthesizing findings and recommending corrective actions and process enhancements.
Travel as required (less than 25%).
Other duties as assigned 
Qualifications
What our team expects from you? 
Bachelor’s degree in business, legal, or a related field is required. Master’s degree or legal degree is preferred. 
Certification in project methodology or Agile practices (such as Six Sigma, PMP, PgMP, PfMP, CAPM, PMI-PBA, PMI-ACP, or PMI-RMP), or the ability to obtain certification within one year of hire is required.
5+ years in healthcare-related experience required.
3 years of experience in project management from initiation through implementation is required. 
2+ years of experience in regulatory review, document development and presentation, prescription claims reporting, compliance analysis or monitoring, legal analysis, or auditing work is required.
Demonstrated experience using project tracking tools such as MS Project, Azure DevOps (ADO), PPM Pro, Smartsheet, or similar platforms to manage timelines, documentation, and cross‑functional project deliverables required.
Participate in, adhere to, and support compliance program objectives 
The ability to consistently interact cooperatively and respectfully with other employees 
What can you expect from Navitus? 
Top of the industry benefits for Health, Dental, and Vision insurance 
20 days paid time off 
4 weeks paid parental leave 
9 paid holidays 
401K company match of up to 5% - No vesting requirement 
Adoption Assistance Program 
Flexible Spending Account 
Educational Assistance Plan and Professional Membership assistance 
Referral Bonus Program – up to $750! 
#LI-Remote
Location : Address
Remote 
Location : Country
US

Project Manager, Regulatory Implementation

Candidates must have 10+ years of regulatory affairs or project management experience, with a proven track record managing global submissions like NDA, BLA, or MAA, and deep expertise in the integrated drug development process. Strong project management skills, proficiency with relevant software, excellent leadership abilities, and demonstrated risk mitigation expertise are required.

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. 

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You’ll Do:
The Director of Global Regulatory Affairs (Submission Project Management) is responsible for leading regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This role combines strategic leadership with hands-on project management to ensure timely and high-quality submissions that support product approvals, lifecycle management, and organizational growth.
Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
Responsibilities:
Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
Provide guidance on evolving global regulatory landscapes, including guidelines, regulations, and other factors related to regulatory filings
Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
Oversee project team delivery of the marketing authorization applications
Liaising with regulatory operations department to ensure all components are identified on the submission content plans and submissions meet technical, formatting, and compliance standards
Develop and manage marketing authorization project timelines and deliverables
Identify risks and manage operational risks, implementing mitigation/contingency strategies to ensure submission success
Track progress and report status updates to executive leadership
Establish best practices and SOPs as needed for marketing application related submission processes
Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines
Build strong collaborative relationships across departments
Required Qualifications:
10+ years (8+ with advanced degree) of regulatory affairs and/or project management experience
Proven track record managing global submissions (NDA, BLA, MAA)
Deep expertise in the integrated drug development process, ensuring seamless progression from discovery through commercialization
Collaborated effectively across multidisciplinary teams to identify innovative solutions and alternatives, driving positive business outcomes
Expertly assessed and mitigated risk within a highly regulated environment, maintaining compliance while advancing critical projects
Strong project management skills (PMP certification a plus), with proficiency in Microsoft Project, SmartSheet, or Planisware
Excellent communication, organizational, and leadership abilities
Ability to thrive in a fast-paced, deadline-driven environment
Demonstrated negotiation and influence skills
Preferred Qualifications:
Experience in international regulatory submissions and regulatory interactions
Previous regulatory or leadership assignments across multiple countries
Education:
Bachelor’s degree with regulatory and/or project management experience in the pharmaceutical industry, 
Advanced degree in Life Sciences, Regulatory Affairs, or related field (PhD, PharmD, MS preferred)
Salary Range
$192,000—$235,000 USD
For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify:
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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