Regulatory Affairs Director Jobs
Regulatory Affairs Director jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer products, from senior manager to VP level, with specializations in FDA submissions, global regulatory strategy, and clinical trial compliance. Find a role that fits from the openings below and apply directly.
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INTRODUCTION
MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.
ROLE AND RESPONSIBILITIES
The Associate Director, Regulatory Affairs, Spine will be a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA. The Associate Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.
Responsibilities and Duties
- Develop and execute regulatory services for client companies, including however not limited to:
- Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)
- Regulatory Strategy, Analysis & Development
- Design, Review & Implement Pre-Clinical Testing
- Manage junior members of MCRA’s regulatory department.
- Perform business development functions to secure new clients and projects.
- Work directly with client companies and/or regulatory bodies without senior MCRA staff oversight.
- Provide project leadership while maintaining sole relationship with client companies.
- Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.
- Stay current on relevant medical device regulatory requirements.
- Attend conferences and meetings as needed.
- Complete other duties and projects as assigned.
BASIC QUALIFICATIONS
Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
Certification/Licensure: Not applicable.
Experience: Minimum seven years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions. Work experience must include managing regulatory submissions.
Preferred Knowledge, Skills, and Experience
- An understanding of clinical research and data analysis is required.
- Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).
- Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.
- International regulatory experience including developing Technical Documentation and CERs is advantageous.
- Understanding of your team's regulatory landscape, including the breadth of services, how they interact, and how data flows between deliverables.
- Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.
- Possesses an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.
- Strong research, analytical, critical-thinking and problem-solving skills.
- Strong professionalism with customer relations and managing client relationships.
- Ability to lead junior staff effectively and mentor junior team members.
- Able to lead multiple projects without support; takes initiative and ownership of results; demonstrates a high-level of self-accountability.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- PC/Technical skills- MS Office, Excel, Word, PowerPoint.
- Must be punctual, polished, and professional.
- Effective interpersonal skills: shows confidence with subject matter and “calm under pressure” approach and style.
- Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
COMPENSATION
The potential base pay range for this role, when annualized, is $107,800.00 - $300,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
INTRODUCTION
MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.
ROLE AND RESPONSIBILITIES
The Associate Director, Regulatory Affairs, Spine will be a critical team member supporting regulatory strategy and submissions for the firm’s clientele. The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, and communicating with regulatory bodies and clients. The projects may be for companies in MCRA therapeutic areas, other MCRA areas of regulatory and scientific expertise, and/or other growing therapeutic concentrations of MCRA. The Associate Director will also manage various personnel during various projects, as well as act as a mentor and trainer for junior employees.
Responsibilities and Duties
- Develop and execute regulatory services for client companies, including however not limited to:
- Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs)
- Regulatory Strategy, Analysis & Development
- Design, Review & Implement Pre-Clinical Testing
- Manage junior members of MCRA’s regulatory department.
- Perform business development functions to secure new clients and projects.
- Work directly with client companies and/or regulatory bodies without senior MCRA staff oversight.
- Provide project leadership while maintaining sole relationship with client companies.
- Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance.
- Stay current on relevant medical device regulatory requirements.
- Attend conferences and meetings as needed.
- Complete other duties and projects as assigned.
BASIC QUALIFICATIONS
Education: Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
Certification/Licensure: Not applicable.
Experience: Minimum seven years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics, developing regulatory deliverables and submissions. Work experience must include managing regulatory submissions.
Preferred Knowledge, Skills, and Experience
- An understanding of clinical research and data analysis is required.
- Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).
- Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise.
- International regulatory experience including developing Technical Documentation and CERs is advantageous.
- Understanding of your team's regulatory landscape, including the breadth of services, how they interact, and how data flows between deliverables.
- Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written, including medical/technical writing, and verbal communication and presentation skills.
- Possesses an understanding of engineering and a biological background to assist with pre-clinical and clinical strategies and is able to effectively communicate these strategies to internal team members and clients.
- Strong research, analytical, critical-thinking and problem-solving skills.
- Strong professionalism with customer relations and managing client relationships.
- Ability to lead junior staff effectively and mentor junior team members.
- Able to lead multiple projects without support; takes initiative and ownership of results; demonstrates a high-level of self-accountability.
- Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
- PC/Technical skills- MS Office, Excel, Word, PowerPoint.
- Must be punctual, polished, and professional.
- Effective interpersonal skills: shows confidence with subject matter and “calm under pressure” approach and style.
- Knowledge and experience utilizing research evidence and providing statistical analysis is advantageous.
COMPENSATION
The potential base pay range for this role, when annualized, is $107,800.00 - $300,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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Find JobsRegulatory Affairs Director Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- Revolution Medicines16
- Insmed Incorporated5
- AbbVie4
- Eli Lilly3
Top Industries Hiring
- Biotechnology & Pharmaceuticals78
- Healthcare & Medical Services8
- Medical Devices7
- Science & Research6
- Consulting & Professional Services4
What Employers Look For
The qualifications that appear most often in regulatory affairs director jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- Eight or more years of regulatory affairs experience in pharmaceuticals, biologics, or medical devices
- Demonstrated experience leading FDA submissions including INDs, NDAs, BLAs, or 510(k)s
- RAC certification from the Regulatory Affairs Professionals Society preferred or required
- Proficiency with electronic submissions, eCTD format, and regulatory information management systems
- Experience managing regulatory teams and cross-functional project timelines from submission through approval
Tips for Your Regulatory Affairs Director Job Search
Tailor your resume to submission types
Regulatory affairs directors are hired for specific submission experience, whether that's 510(k)s, NDAs, BLAs, or EU CE mark dossiers. Make sure your resume names the exact submission types you've led, not just broad regulatory experience.
Show cross-functional leadership explicitly
Job descriptions for this role almost always require experience managing relationships with clinical, legal, and manufacturing teams. Describe specific instances where you aligned multiple departments on a regulatory strategy or resolved a submission timeline conflict.
Target openings by product stage
Companies in early-stage development need directors who can build regulatory infrastructure from scratch, while commercial-stage companies want someone who can defend approvals and manage post-market compliance. Filter your search by company stage to find where your experience lands.
Apply early to roles that fit
Migrate Mate lists regulatory affairs director openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Prepare case studies for your interview
Hiring managers at the director level expect you to walk through a real regulatory challenge you owned, including how you resolved an agency dispute, managed a label negotiation, or recovered a delayed submission. Have two or three concrete examples ready before any first-round call.
Negotiate scope before accepting an offer
Ask directly whether the role owns regulatory strategy or executes someone else's. Directors who report to a Chief Regulatory Officer often have narrower authority than titles suggest. Clarifying decision-making scope before you accept prevents misaligned expectations once you start.
Regulatory Affairs Director Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory affairs directors?
The companies hiring the most regulatory affairs directors right now include Revolution Medicines, Insmed Incorporated, and Revolution Medicines, with the largest share of openings in California, Massachusetts, and New Jersey, based on current listings on Migrate Mate as of June 2026. Hiring tends to concentrate at companies with active clinical pipelines or recent product launches requiring post-approval regulatory support.
How many regulatory affairs director jobs are remote?
About 34% of regulatory affairs director openings are fully remote or hybrid as of June 2026, making it one of the more flexible senior roles in the life sciences. Strategic and policy-focused positions tend to allow remote arrangements more often than roles tied to manufacturing sites or in-person agency meetings.
How do you become a regulatory affairs director?
Most regulatory affairs directors start in a specialist or associate director role, building hands-on experience with agency submissions and product approvals. From there, you develop cross-functional leadership skills by managing submission teams or owning a product program end to end. Earning RAC certification and building direct FDA or international agency interaction experience are the steps that most reliably accelerate the move into director-level roles.
Can you get a regulatory affairs director job without director-level experience?
Yes, some companies hire senior regulatory managers or associate directors into a regulatory affairs director title when the candidate has deep submission expertise and has informally led teams or programs. The strongest path from below the director level is to document ownership of a full submission lifecycle and show that you coordinated regulatory strategy across clinical, manufacturing, or commercial partners, even without a formal management title.
What does the regulatory affairs director interview process look like?
The process typically starts with a recruiter or HR screen focused on submission type and therapeutic area experience, followed by a hiring manager conversation that goes deeper on regulatory strategy and agency interactions. Later rounds usually include a panel with cross-functional partners from clinical, legal, or quality, and sometimes a presentation where you walk through a past regulatory challenge or proposed approach to a mock scenario.
Where can I find and apply to regulatory affairs director jobs?
You can find and apply to regulatory affairs director jobs on Migrate Mate, which lists current openings from across the United States. Search for roles that match your therapeutic area, submission type experience, and preferred location, then apply directly to each listing that fits.
See All 102+ Regulatory Affairs Director Jobs
Jump back to the full list of openings and apply to any regulatory affairs director role that fits.
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