Sr. Regulatory Ad Promo Manager
Neurocrine Biosciences
August 06, 2026
Remote friendly (San Diego, CA)
United States
Corporate Functions
About The Role
Responsible for leading the regulatory review of medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads the Promotional Review Committee (PRC) process for assigned products and independently reviews materials as a subject matter expert to ensure compliance with FDA regulations, guidance, and internal policies. Works closely with cross-functional teams to support compliant and effective promotional strategies, assess regulatory risk, and ensure timely submissions to FDA.
Your Contributions (include, But Are Not Limited To)
- Leads the PRC process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines.
- Represents Regulatory Affairs on the Medical Review Committee (MRC) and conducts regulatory review for materials used by field medical teams.
- Independently reviews advertising and promotional materials; provides risk-based regulatory guidance integrating scientific, regulatory, and business considerations.
- Ensures timely and accurate review and submission of promotional materials, including FDA Form 2253 submissions.
- Evaluates FDA guidance, policies, enforcement trends, and the regulatory environment to assess and communicate regulatory risk.
- Ensures communications and promotional claims comply with approved product labeling, applicable laws, internal policies, and external regulations.
- Maintains standard operating procedures and department working practices; may mentor junior team members.
Requirements
- BS/BA in Life/Health Sciences (or related) AND 8+ years Regulatory Affairs experience in biotech/pharma/device, including significant Advertising & Promotion process management. OR
- Master’s in Life/Health Science (or related) AND 6+ years similar experience.
- Proven advertising/promotional review committee experience with strong knowledge of FDA guidance/regulations.
- Strong leadership/mentoring, communication, analytical/problem-solving, project management, and organizational skills.
- Strong computer skills; knowledge of electronic document management systems (e.g., Veeva Vault or similar).
- Proficiency in Microsoft Office and Adobe Professional.
Benefits (explicitly stated)
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
Responsible for leading the regulatory review of medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads the Promotional Review Committee (PRC) process for assigned products and independently reviews materials as a subject matter expert to ensure compliance with FDA regulations, guidance, and internal policies. Works closely with cross-functional teams to support compliant and effective promotional strategies, assess regulatory risk, and ensure timely submissions to FDA.
Your Contributions (include, But Are Not Limited To)
- Leads the PRC process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines.
- Represents Regulatory Affairs on the Medical Review Committee (MRC) and conducts regulatory review for materials used by field medical teams.
- Independently reviews advertising and promotional materials; provides risk-based regulatory guidance integrating scientific, regulatory, and business considerations.
- Ensures timely and accurate review and submission of promotional materials, including FDA Form 2253 submissions.
- Evaluates FDA guidance, policies, enforcement trends, and the regulatory environment to assess and communicate regulatory risk.
- Ensures communications and promotional claims comply with approved product labeling, applicable laws, internal policies, and external regulations.
- Maintains standard operating procedures and department working practices; may mentor junior team members.
Requirements
- BS/BA in Life/Health Sciences (or related) AND 8+ years Regulatory Affairs experience in biotech/pharma/device, including significant Advertising & Promotion process management. OR
- Master’s in Life/Health Science (or related) AND 6+ years similar experience.
- Proven advertising/promotional review committee experience with strong knowledge of FDA guidance/regulations.
- Strong leadership/mentoring, communication, analytical/problem-solving, project management, and organizational skills.
- Strong computer skills; knowledge of electronic document management systems (e.g., Veeva Vault or similar).
- Proficiency in Microsoft Office and Adobe Professional.
Benefits (explicitly stated)
- Retirement savings plan (with company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).