Regulatory Affairs Jobs
Regulatory Affairs jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer products, at every level from associate to director and VP, with specializations in submissions, labeling, and CMC. Find a role that fits from the openings below and apply directly.
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Showing 5 of 326+ Regulatory Affairs jobs
Description Overview
As Director of Regulatory Affairs - Cluster (North America), you are accountable for in-market regulatory activation, execution, and health authority engagement across the cluster. You translate Category Regulatory strategies into effective local execution, ensuring compliant, timely approvals and enabling business growth across North America.
You act as the primary regulatory interface to health authorities (e.g., FDA and Health Canada), and as a strategic partner to in-market commercial teams. You are accountable for regulatory delivery performance, market risk management, and submission readiness, working in partnership with Category Regulatory Affairs and LCM & Regulatory Operations.
This role sits within the Cluster Regulatory Affairs pillar, accountable for in-market execution and regulatory delivery. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally. LCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Final submission sign-off is owned by Markets in partnership with Category Regulatory Affairs; this role leads readiness, execution, and regulatory recommendation.
Scope of the Role
Cluster Regulatory Leadership
- Define and lead the regional regulatory execution priorities, aligned to Category strategies - representing the function on the Commercial Cluster Lead team and being a business enabling partner at Cluster level
- Translate Category regulatory strategies into actionable market execution plans, providing key market insight and regulatory intelligence
- Lead engagement with FDA and Health Canada
- Collaborate with regional commercial, medical, quality, and policy teams to ensure regulatory execution supports business growth and market competitiveness
Regulatory Operations & Lifecycle Management
- Own cluster regulatory delivery performance and set submission priorities aligned to commercial objectives
- Partner with LCM & Reg Ops ensuring effective execution of post-launch lifecycle activities
Health Authority Engagement & Policy Influence
- Maintain relationships with health authorities across the cluster, representing Perrigo in regional industry associations and policy forums
- Provide strategic input to Category Regulatory Affairs and enterprise governance on regulatory trends, policy developments, and external risks
Innovation Enablement & Business Growth
- Partner with Category Regulatory team to support innovation pipelines. Lead in-market regulatory execution for innovation
- Provide market-specific feasibility, regulatory pathway implications, and timing assessments to inform portfolio decisions and launch planning
- Regulatory business partner to commercial teams
- Support business development, licensing, and M&A activities
- Identify opportunities to optimize regulatory pathways, accelerate approvals, and enable competitive advantage
Compliance, Governance & Risk Management
- Ensure compliance with all applicable regulatory requirements at the market level within the cluster
- Own cluster regulatory risk register
- Lead inspection readiness and regulatory response
- Primary escalation point for regulatory risks and escalate to Category RA governance for alignment and decision-making
- Embed regulatory intelligence into business planning and decision-making
- Ensure appropriate regulatory governance is applied to submissions, claims, and labelling decisions
Regional Vigilance
- Accountable for regulatory vigilance compliance delivered in partnership with Global Patient Safety
- Ensure inspection and audit readiness for vigilance-related regulatory requirements
- Provide regulatory oversight to ensure alignment between local market requirements and global vigilance frameworks
- Support identification, assessment, mitigation of safety-related regulatory risks
- Ensure timely and accurate regulatory reporting and documentation related to vigilance obligations
Team Leadership & Capability Building
- Lead, develop, and inspire high-performing cluster regulatory team aligned with Perrigo core values and behaviours
- Build and strengthen capability in health authority engagement, regulatory execution, and business partnering
- Drive alignment and ways of working across Cluster Regulatory Affairs, Category Regulatory Affairs, and LCM & Regulatory Operations, ensuring clarity of roles, responsibilities, and decision-making
- Act as a strategic leader and role model within the organisation, promoting enterprise thinking and cross-functional collaboration across Regulatory, R&D, Commercial, Quality, and Medical
Experience Required
- Degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field.
- 15+ years of progressive regulatory affairs experience within consumer health, pharmaceuticals, or adjacent sectors
- Demonstrated experience in leading regulatory strategy execution and delivery at market or regional level, including health authority interactions.
- Strong experience with North America regulatory frameworks (e.g., FDA and/or Health Canada), or equivalent regional expertise where applicable.
- Proven ability to act as the primary regulatory interface with health authorities, including managing complex submissions, negotiations, and issue resolution.
- Strong business acumen with the ability to partner effectively with commercial and cross-functional stakeholders to enable growth.
Description Overview
As Director of Regulatory Affairs - Cluster (North America), you are accountable for in-market regulatory activation, execution, and health authority engagement across the cluster. You translate Category Regulatory strategies into effective local execution, ensuring compliant, timely approvals and enabling business growth across North America.
You act as the primary regulatory interface to health authorities (e.g., FDA and Health Canada), and as a strategic partner to in-market commercial teams. You are accountable for regulatory delivery performance, market risk management, and submission readiness, working in partnership with Category Regulatory Affairs and LCM & Regulatory Operations.
This role sits within the Cluster Regulatory Affairs pillar, accountable for in-market execution and regulatory delivery. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally. LCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Final submission sign-off is owned by Markets in partnership with Category Regulatory Affairs; this role leads readiness, execution, and regulatory recommendation.
Scope of the Role
Cluster Regulatory Leadership
- Define and lead the regional regulatory execution priorities, aligned to Category strategies - representing the function on the Commercial Cluster Lead team and being a business enabling partner at Cluster level
- Translate Category regulatory strategies into actionable market execution plans, providing key market insight and regulatory intelligence
- Lead engagement with FDA and Health Canada
- Collaborate with regional commercial, medical, quality, and policy teams to ensure regulatory execution supports business growth and market competitiveness
Regulatory Operations & Lifecycle Management
- Own cluster regulatory delivery performance and set submission priorities aligned to commercial objectives
- Partner with LCM & Reg Ops ensuring effective execution of post-launch lifecycle activities
Health Authority Engagement & Policy Influence
- Maintain relationships with health authorities across the cluster, representing Perrigo in regional industry associations and policy forums
- Provide strategic input to Category Regulatory Affairs and enterprise governance on regulatory trends, policy developments, and external risks
Innovation Enablement & Business Growth
- Partner with Category Regulatory team to support innovation pipelines. Lead in-market regulatory execution for innovation
- Provide market-specific feasibility, regulatory pathway implications, and timing assessments to inform portfolio decisions and launch planning
- Regulatory business partner to commercial teams
- Support business development, licensing, and M&A activities
- Identify opportunities to optimize regulatory pathways, accelerate approvals, and enable competitive advantage
Compliance, Governance & Risk Management
- Ensure compliance with all applicable regulatory requirements at the market level within the cluster
- Own cluster regulatory risk register
- Lead inspection readiness and regulatory response
- Primary escalation point for regulatory risks and escalate to Category RA governance for alignment and decision-making
- Embed regulatory intelligence into business planning and decision-making
- Ensure appropriate regulatory governance is applied to submissions, claims, and labelling decisions
Regional Vigilance
- Accountable for regulatory vigilance compliance delivered in partnership with Global Patient Safety
- Ensure inspection and audit readiness for vigilance-related regulatory requirements
- Provide regulatory oversight to ensure alignment between local market requirements and global vigilance frameworks
- Support identification, assessment, mitigation of safety-related regulatory risks
- Ensure timely and accurate regulatory reporting and documentation related to vigilance obligations
Team Leadership & Capability Building
- Lead, develop, and inspire high-performing cluster regulatory team aligned with Perrigo core values and behaviours
- Build and strengthen capability in health authority engagement, regulatory execution, and business partnering
- Drive alignment and ways of working across Cluster Regulatory Affairs, Category Regulatory Affairs, and LCM & Regulatory Operations, ensuring clarity of roles, responsibilities, and decision-making
- Act as a strategic leader and role model within the organisation, promoting enterprise thinking and cross-functional collaboration across Regulatory, R&D, Commercial, Quality, and Medical
Experience Required
- Degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field.
- 15+ years of progressive regulatory affairs experience within consumer health, pharmaceuticals, or adjacent sectors
- Demonstrated experience in leading regulatory strategy execution and delivery at market or regional level, including health authority interactions.
- Strong experience with North America regulatory frameworks (e.g., FDA and/or Health Canada), or equivalent regional expertise where applicable.
- Proven ability to act as the primary regulatory interface with health authorities, including managing complex submissions, negotiations, and issue resolution.
- Strong business acumen with the ability to partner effectively with commercial and cross-functional stakeholders to enable growth.
See All 326+ Regulatory Affairs Jobs
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Find Regulatory Affairs JobsRegulatory Affairs Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- Revolution Medicines21
- Abbott17
- Dentsply Sirona16
- AbbVie13
- Evalve8
Top Industries Hiring
- Biotechnology & Pharmaceuticals163
- Medical Devices56
- Healthcare & Medical Services36
- Consulting & Professional Services20
- Education13
What Employers Look For
The qualifications that appear most often in regulatory affairs jobs.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field
- Experience with FDA submissions including INDs, NDAs, BLAs, or 510(k)s
- Knowledge of 21 CFR regulations and ICH guidelines
- Proficiency with regulatory information management systems such as Veeva Vault
- Regulatory Affairs Certification (RAC) from RAPS preferred or required
- Strong technical writing skills for regulatory documents and agency correspondence
Tips for Your Regulatory Affairs Job Search
Tailor your resume to submission type
Hiring managers scan for IND, NDA, BLA, 510(k), or PMA experience specific to the role. Name the exact submission types you've owned, not just 'regulatory submissions,' and match the agency acronyms in the job listing.
Apply early to roles that fit
Migrate Mate lists regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
List your agency interaction experience explicitly
Roles that require FDA or EMA correspondence want proof you've written responses to information requests or managed pre-submission meetings. Call this out in a dedicated experience line, not buried in a bullet about team support.
Filter openings by product type early
Regulatory requirements differ sharply between drugs, biologics, devices, and combination products. Targeting openings that match your product experience avoids the common trap of applying broadly and getting filtered out by automated screening.
Prepare a submission timeline you can walk through
Interviewers routinely ask you to describe a regulatory submission from kick-off to approval. Have one real example ready with the product type, the pathway chosen, the timeline, and any agency feedback you addressed.
Negotiate start date around any pending certifications
If you're completing RAC or another credential, tell the hiring manager before the offer stage. Employers in this field understand certification timelines and many will adjust a start date rather than lose a strong candidate.
Regulatory Affairs Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory affairs professionals?
The companies hiring the most regulatory affairs professionals right now include Revolution Medicines, Abbott, and Dentsply Sirona, with the largest share of openings in California, Massachusetts, and Pennsylvania, based on current listings on Migrate Mate as of June 2026. Pharmaceutical and medical device companies consistently account for the largest volume of postings.
How many regulatory affairs jobs are remote?
About 34% of regulatory affairs openings are fully remote or hybrid as of June 2026, making it one of the more flexible specialty functions in the life sciences. Roles focused on submissions strategy, labeling review, and regulatory intelligence tend to offer the most remote flexibility, while positions involving lab oversight or on-site agency interactions are more often on-site.
How do you become a regulatory affairs professional?
Start with a bachelor's degree in a life science, pharmacy, or chemistry field, then gain experience in a regulated industry through a quality, clinical, or scientific role. Build familiarity with FDA pathways and ICH guidelines through hands-on project work. Pursuing the RAC credential from RAPS strengthens your candidacy significantly. Many professionals transition from quality assurance, medical writing, or clinical operations roles.
How do you get a regulatory affairs job with little experience?
Target entry-level associate or coordinator roles at CROs, generic drug companies, or medical device startups, where submission volume is high and hands-on learning happens faster. Volunteer to support document preparation or regulatory tracking in your current role to build a paper trail. Completing an RAC prep course signals commitment even before you sit the exam, and it gives you vocabulary that resonates in interviews.
What does the regulatory affairs interview process look like?
Most regulatory affairs hiring processes include an initial recruiter screen, a technical interview with a hiring manager or senior regulatory professional, and at least one panel round with cross-functional stakeholders such as R&D, quality, or legal. Expect scenario questions about submission strategy, agency interactions, and how you've resolved conflicting regulatory requirements. A writing exercise or case study is common for senior roles.
Where can I find and apply to regulatory affairs jobs?
You can find and apply to regulatory affairs jobs on Migrate Mate, which lists current openings from across the United States in one place. Search for roles that match your product experience and submission background, then apply directly to each listing that fits.
See All 326+ Regulatory Affairs Jobs
Jump back to the full list of openings and apply to any regulatory affairs role that fits.
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