Regulatory Scientist Jobs
Regulatory Scientist jobs are open across pharmaceuticals, biotechnology, medical devices, and consumer products, from entry-level associate to senior principal and director, with specializations in drug development, clinical submissions, and environmental compliance. Find a role that fits below and apply directly.
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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 Scientist Jobs by Experience Level
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Find Regulatory Scientist JobsRegulatory Scientist Job Market
Who's Hiring
- Exponent10
- Organon Pharmaceuticals3
- Merck2
- Elanco2
- Stepan2
Top Industries Hiring
- Consulting & Professional Services
- Biotechnology & Pharmaceuticals
What Employers Look For
The qualifications that appear most often in regulatory scientist jobs.
- Bachelor's or advanced degree in life sciences, chemistry, pharmacy, or engineering
- Experience preparing and submitting regulatory filings such as INDs, NDAs, BLAs, or 510(k)s
- Working knowledge of FDA regulations, ICH guidelines, and GxP requirements
- Proficiency with regulatory information management systems and document control platforms
- Strong technical writing skills for preparing summaries, briefings, and agency correspondence
- RAC certification from the Regulatory Affairs Professionals Society preferred for senior roles
Tips for Your Regulatory Scientist Job Search
Tailor your resume to submission types
Hiring managers scan for the specific submission types you've worked on, such as INDs, NDAs, BLAs, or 510(k)s. Name the submission type and the therapeutic area or device category in your bullet points, not just the agency you filed with.
Apply early to roles that fit
Migrate Mate lists regulatory scientist openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Highlight your agency interaction experience
Many postings prioritize candidates who have participated in direct agency correspondence or meetings. Call out any experience drafting responses to FDA information requests, preparing briefing documents, or attending pre-submission meetings.
Read job postings for the regulatory pathway
A role focused on 510(k) clearances requires a different specialization than one centered on PMA approvals or EU MDR compliance. Filter openings by the regulatory framework mentioned, not just the job title, to avoid wasting time on poor-fit applications.
Prepare a case study for your interview
Interviewers for regulatory scientist roles consistently ask how you resolved a deficiency letter or navigated an unexpected agency question. Prepare a concise two-minute narrative covering the problem, your regulatory strategy, and the outcome before your first screening call.
Negotiate using your submission history
When discussing compensation, anchor your ask to the number and complexity of regulatory submissions you've led to approval. A candidate who independently managed a complex NDA carries measurably more value than one with supporting experience, and that distinction supports a stronger offer.
Regulatory Scientist Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory scientists?
The most active employers for regulatory scientists right now are Exponent, Organon Pharmaceuticals, and Merck, and the most openings are in New Jersey, District of Columbia, and Illinois, based on current listings on Migrate Mate as of November 2026. Demand is highest at large pharmaceutical manufacturers, medical device companies, and contract research organizations managing multi-product regulatory portfolios.
How many regulatory scientist jobs are remote?
About 64% of regulatory scientist openings are fully remote or hybrid as of November 2026, reflecting the document-heavy and cross-functional nature of much of the work. Roles focused on regulatory strategy, dossier preparation, and labeling review tend to offer the most remote flexibility, while positions requiring lab coordination or on-site agency interactions are more likely to be in-office.
How do you become a regulatory scientist?
Start with a degree in a life science, pharmacy, chemistry, or engineering discipline, then build hands-on exposure to regulatory submissions through entry-level roles in quality assurance, clinical operations, or medical writing. Pursue RAC certification from the Regulatory Affairs Professionals Society to formalize your credentials. Specialize in a product category such as biologics, combination products, or diagnostics to sharpen your competitiveness for senior openings.
Can you get hired as a regulatory scientist with little experience?
Yes, entry-level regulatory scientist roles exist, and they typically look for candidates with a relevant science degree, familiarity with FDA guidance documents, and exposure to regulated environments through internships, co-ops, or adjacent roles in quality or clinical research. Demonstrating that you've read and can interpret FDA guidance for the company's product type, even without direct submission experience, sets you apart from other early-career applicants.
What does the regulatory scientist interview process look like?
Most processes start with a recruiter phone screen focused on your regulatory background and submission experience, followed by a hiring manager interview that probes your knowledge of relevant agency frameworks and your approach to navigating agency feedback. Later rounds often include a panel with cross-functional colleagues from R&D, quality, or clinical affairs. Some employers add a written exercise asking you to review a mock deficiency letter or draft a brief regulatory strategy summary.
Where can I find and apply to regulatory scientist jobs?
You can find and apply to regulatory scientist jobs on Migrate Mate, which lists current openings from across the United States in one place. Find roles that match your specialization and experience level, then apply directly to each listing.
See All 38 Regulatory Scientist Jobs
Find roles that match your experience and apply in just a few clicks.
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