Mid Level Senior Director Regulatory Affairs Jobs
Mid level senior director regulatory affairs jobs go to professionals ready to own complex submissions, lead cross-functional workstreams, and deliver regulatory strategy with limited oversight. Roles are distributed across on-site, hybrid, and remote settings in Medical Devices, Healthcare & Medical Services, and Consulting & Professional Services, with employers like VNS Health, Katalyst Healthcares & Life Sciences, and BD hiring at this level now.
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Job Summary:
The Regulatory Affairs Manager is responsible for managing Regulatory Affairs activities across all functional areas – non-clinical, clinical, CMC, and advertising/promotional (Ad Promo) for both investigational and marketed products. This is a cross-functional role that partners with internal and external stakeholders to ensure strategic alignment and regulatory compliance throughout the product life cycle.
The ideal candidate will have a solid understanding of regulatory requirements across development and commercial stages, including INDs, CTAs, BLAs, global authority interactions, and promotional material review. This is a hands-on role in a fast-paced environment that requires flexibility, attention to detail, and strong communication skills.
Reporting to: Associate Director, Regulatory Affairs
Location: Remote - travel <15%
Responsibilities/Essential Duties:
- Manage the advertising and promotional submissions (2253s) related to the BLA and serve as the RA representative on the Promotional Review Committee.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Manage the preparation, review, and submission of regulatory documents across all modules (non-clinical, clinical and CMC) for IND/CTA, BLA/MAA, and other global submissions documents; may manage e-submission vendors.
- Collaborate on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, and annual reports).
- Ensure timely preparation of organized and scientifically valid applications.
- Interact with regulatory agencies on defined matters.
- Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
- Mentor, guide and train direct reports.
- May be required to travel up to 15%.
Basic Qualifications:
- Bachelor's degree & 5+ years' directly related experience.
- Direct experience in promotional material review and knowledge of FDA OPDP requirements.
Preferred Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field.
- Minimum 5-7 years' experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics.
- Regulatory Affairs certification or equivalent training.
- Experience in preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format.
- Knowledge of US, EU, Health Canada, Australia, and ICH regulatory requirements.
- Experience directly interfacing with regulatory authorities.
Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists.
What Revance invests in you:
- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Job Summary:
The Regulatory Affairs Manager is responsible for managing Regulatory Affairs activities across all functional areas – non-clinical, clinical, CMC, and advertising/promotional (Ad Promo) for both investigational and marketed products. This is a cross-functional role that partners with internal and external stakeholders to ensure strategic alignment and regulatory compliance throughout the product life cycle.
The ideal candidate will have a solid understanding of regulatory requirements across development and commercial stages, including INDs, CTAs, BLAs, global authority interactions, and promotional material review. This is a hands-on role in a fast-paced environment that requires flexibility, attention to detail, and strong communication skills.
Reporting to: Associate Director, Regulatory Affairs
Location: Remote - travel <15%
Responsibilities/Essential Duties:
- Manage the advertising and promotional submissions (2253s) related to the BLA and serve as the RA representative on the Promotional Review Committee.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Manage the preparation, review, and submission of regulatory documents across all modules (non-clinical, clinical and CMC) for IND/CTA, BLA/MAA, and other global submissions documents; may manage e-submission vendors.
- Collaborate on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, and annual reports).
- Ensure timely preparation of organized and scientifically valid applications.
- Interact with regulatory agencies on defined matters.
- Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
- Mentor, guide and train direct reports.
- May be required to travel up to 15%.
Basic Qualifications:
- Bachelor's degree & 5+ years' directly related experience.
- Direct experience in promotional material review and knowledge of FDA OPDP requirements.
Preferred Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or a related field.
- Minimum 5-7 years' experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics.
- Regulatory Affairs certification or equivalent training.
- Experience in preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format.
- Knowledge of US, EU, Health Canada, Australia, and ICH regulatory requirements.
- Experience directly interfacing with regulatory authorities.
Company Summary:
Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company's vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance's award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists.
What Revance invests in you:
- Competitive Compensation including base salary and annual performance bonus.
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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Who's Hiring
Top Industries Hiring
- Medical Devices
- Healthcare & Medical Services
- Consulting & Professional Services
- Technology & Software
- Biotechnology & Pharmaceuticals
Mid Level Senior Director Regulatory Affairs Jobs: Frequently Asked Questions
How do I get a mid level senior director regulatory affairs job?
Position your experience around regulatory submissions you have led independently, not just supported. Highlight your familiarity with agency interactions, your ability to interpret evolving guidance, and any cross-functional ownership you have held. Applications that connect your background to a specific regulatory pathway, such as 510(k), NDA, or BLA, and show measurable outcomes will stand out at this level.
Which companies hire mid level senior director regulatory affairss?
Companies hiring mid level senior director regulatory affairss right now include VNS Health, Katalyst Healthcares & Life Sciences, and BD, based on current listings on Migrate Mate as of November 2026. Both large pharmaceutical and medical device manufacturers and specialized biotech firms actively recruit at this level, particularly those with active pipelines moving through regulatory review.
Are there remote mid level senior director regulatory affairs jobs?
Yes, though availability varies by company and therapeutic area. About 60% of mid level senior director regulatory affairs openings are remote or hybrid as of November 2026, reflecting the document-intensive nature of much regulatory work. Roles tied to lab operations or frequent agency meetings tend to require more on-site presence than those focused on submissions strategy or policy analysis.
How do I move up to a mid level senior director regulatory affairs role?
Growth into a mid level senior director regulatory affairs role comes from building deeper ownership over time. Start by taking primary responsibility for discrete submissions or agency responses rather than supporting a senior colleague. Strengthen your understanding of a specific regulatory framework, develop relationships with cross-functional partners in clinical, quality, and legal, and demonstrate that your decisions hold up under scrutiny without constant review.
Which industries hire the most mid level senior director regulatory affairss?
Mid Level senior director regulatory affairs roles concentrate in Medical Devices, Healthcare & Medical Services, and Consulting & Professional Services, based on current listings on Migrate Mate as of November 2026. These sectors drive hiring at this level because active product development pipelines and shifting agency expectations create sustained demand for professionals who can manage regulatory complexity independently.