Regulatory Project Manager Jobs
Regulatory Project Manager jobs are open across pharmaceuticals, medical devices, financial services, and energy, at every level from associate to senior and director, with specializations in submissions management, compliance program oversight, and cross-functional regulatory strategy. Find a role that fits below and apply directly.
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Showing 5 of 35+ Regulatory Project Manager jobs
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Company Overview:
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet, and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Global Regulatory Project Lead - Biologicals
As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory strategy for novel farm and companion animal biological products. You will serve as the dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies like the USDA’s Center for Veterinary Biologics (CVB). This role requires a strategic professional who can navigate complex agency interactions, influence cross-functional partners (including Global Research and Development (R&D), Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other first-wave countries are successful.
Your Responsibilities:
- Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVB submissions.
- Serve as the dedicated regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
- Act as the primary point of contact for and lead direct engagements with regulatory agencies.
- Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
- Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
- Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.
What You Need to Succeed (minimum qualifications):
- Education: A master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field
- Experience: At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary biologicals.
- Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the USDA – Center of Veterinary Biologics (CVB).
- Guidance & Influence: Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.
What will give you a competitive edge (preferred qualifications):
- Direct USDA-CVB regulatory experience with both farm animal and companion animal products.
- Experience navigating novel regulatory pathways for innovative products.
- Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
- A strong understanding of risk assessment and risk management fundamentals.
- Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).
Additional Information:
- Travel: 10-25%
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
#LI-SC1
Elanco currently anticipates that the base salary for this position could range from $118,000 to $197,000 depending partly on the successful candidate’s qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees. Estimated application closing date is (insert date). Applications will be accepted on an ongoing basis.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Company Overview:
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet, and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Global Regulatory Project Lead - Biologicals
As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory strategy for novel farm and companion animal biological products. You will serve as the dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies like the USDA’s Center for Veterinary Biologics (CVB). This role requires a strategic professional who can navigate complex agency interactions, influence cross-functional partners (including Global Research and Development (R&D), Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other first-wave countries are successful.
Your Responsibilities:
- Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVB submissions.
- Serve as the dedicated regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
- Act as the primary point of contact for and lead direct engagements with regulatory agencies.
- Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
- Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
- Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
- Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.
What You Need to Succeed (minimum qualifications):
- Education: A master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field
- Experience: At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary biologicals.
- Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the USDA – Center of Veterinary Biologics (CVB).
- Guidance & Influence: Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.
What will give you a competitive edge (preferred qualifications):
- Direct USDA-CVB regulatory experience with both farm animal and companion animal products.
- Experience navigating novel regulatory pathways for innovative products.
- Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
- A strong understanding of risk assessment and risk management fundamentals.
- Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).
Additional Information:
- Travel: 10-25%
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
#LI-SC1
Elanco currently anticipates that the base salary for this position could range from $118,000 to $197,000 depending partly on the successful candidate’s qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees. Estimated application closing date is (insert date). Applications will be accepted on an ongoing basis.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Regulatory Project Manager Jobs by Experience Level
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Find JobsRegulatory Project Manager Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Consulting & Professional Services
What Employers Look For
The qualifications that appear most often in regulatory project manager jobs.
- Bachelor's degree in a life sciences, engineering, or related technical field
- Experience coordinating regulatory submissions such as INDs, NDAs, BLAs, or 510(k)s
- Proficiency with project management tools and document management systems
- Knowledge of FDA regulations, ICH guidelines, or relevant industry standards
- PMP certification or equivalent project management credential preferred
- Strong cross-functional communication skills with clinical, quality, and legal teams
Tips for Your Regulatory Project Manager Job Search
Tailor your resume to submission types
Regulatory project managers work across IND, NDA, 510(k), and other submission types. Call out exactly which ones you've coordinated in your resume's experience bullets so hiring managers can match your background to their pipeline without guessing.
Apply early to roles that fit
Migrate Mate lists regulatory project manager openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Highlight cross-functional coordination wins
Regulatory project managers own the handoffs between clinical, quality, medical affairs, and legal. Your resume should name the exact functions you coordinated and the milestone you delivered, not just describe the project type.
Filter openings by regulatory framework
FDA-regulated roles and EMA-focused roles require different experience. When searching, use keywords like 'FDA submissions,' 'ICH guidelines,' or 'EU MDR' to surface openings aligned to the frameworks you actually know.
Prepare a submission timeline story for interviews
Interviewers for regulatory project manager roles frequently ask you to walk through a complex submission from kick-off to agency receipt. Have one complete example ready that covers scope changes, cross-functional delays, and how you kept the timeline on track.
Negotiate scope alongside title and pay
Regulatory project managers often absorb regulatory affairs coordination duties without a title match. Before accepting an offer, clarify whether the role owns project management only or also owns content authoring and agency responses, so your workload matches the job you accepted.
Regulatory Project Manager Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory project managers?
The most active employers for regulatory project managers right now are Elanco, Olema Oncology, and Takeda Pharmaceuticals, and the most openings are in California, Massachusetts, and New York, based on current listings on Migrate Mate as of November 2026. Pharmaceutical companies, medical device manufacturers, and contract research organizations tend to post the highest volumes of regulatory project manager roles.
How many regulatory project manager jobs are remote?
About 53% of regulatory project manager openings are fully remote or hybrid as of November 2026, reflecting broader flexibility in regulated industries. Submission coordination and regulatory strategy roles are most likely to be remote, while roles requiring on-site access to labs, manufacturing facilities, or quality systems tend to require in-person presence.
How do you become a regulatory project manager?
Start with a technical degree in a life science, engineering, or health-related field, then build foundational experience in regulatory affairs, clinical operations, or quality assurance. Develop hands-on exposure to submission preparation and agency communication, earn a project management credential, and move into roles where you own submission timelines and cross-functional coordination directly.
Can you get a regulatory project manager job with little experience?
Yes, entry points exist through regulatory affairs coordinator, project coordinator, and quality associate roles where you support submissions and learn regulatory workflows. Building familiarity with document management systems, submission formatting requirements, and regulatory agency timelines makes you a competitive candidate for junior regulatory project manager openings even without direct title experience.
What does the regulatory project manager interview process look like?
Most processes include an initial recruiter screen, a hiring manager interview focused on submission experience and cross-functional coordination, and a final round with regulatory affairs leadership or a panel. Expect behavioral questions about managing competing timelines, handling scope changes on live submissions, and communicating delays to stakeholders. Some employers add a brief written exercise or case review.
Where can I find and apply to regulatory project manager jobs?
You can find and apply to regulatory project manager jobs on Migrate Mate, which lists current openings from across the United States in one place. Find the roles that match your background and apply directly to each listing without being redirected through multiple platforms.
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Find roles that match your experience and apply in just a few clicks.
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