Director, Regulatory Affairs Advertising & Promotion
Acadia Pharmaceuticals
July 03, 2026
Remote friendly (South San Francisco, CA)
United States
Corporate Functions
Position Summary:
Responsible for leading regulatory review of advertising, promotional, and other external communications to ensure compliance while supporting commercial objectives. Oversees product labeling development, review, and maintenance, and provides regulatory guidance throughout the Medical, Legal, and Regulatory (MLR) review process. Partners cross-functionally to support timely approval and distribution of promotional and disease state materials; primary liaison with FDA OPDP for advertising and promotional submissions; contributes to labeling strategies.
Primary Responsibilities:
- Lead development/oversight of processes and procedures for creation, review, and approval of advertising and promotional materials within the MLR process to ensure regulatory compliance.
- Review external communications, sales/marketing materials, and training for compliance with current regulations and guidance.
- Advise senior management on regulatory strategy and risk analysis tied to commercial strategy.
- Participate in training for sales and marketing on advertising/promotional materials.
- Represent the company to customers/agencies; make presentations on advertising/promotion regulatory issues.
- Other responsibilities as assigned.
Education/Experience/Skills:
- Bachelor’s degree in a scientific discipline or related field; MBA preferred.
- Targeting 10 years progressively responsible Regulatory Affairs experience focused on advertising/promotional regulations (or equivalent combination).
- Experience communicating/negotiating with OPDP and performing risk assessment.
- Experience developing/executing global regulatory strategies and assessing/communicating risk/benefit to senior management.
- Experience with labeling development and lifecycle management.
- Experience with complex negotiations with regulatory authorities; organizational and matrix management.
- Thorough knowledge of US and international pharmaceutical regulations.
- Problem-solving/conflict resolution; strong verbal/written communication; collaboration in cross-functional/global teams.
- Skilled negotiating/influencing senior leaders; creates and communicates clear team vision.
- Willing/able to travel domestically and internationally.
Benefits (as described): Discretionary bonus and equity awards; competitive base salary; medical, dental, vision; employer-paid life/disability/business travel/EAP; 401(k) with 1:1 match up to 5%; Employee Stock Purchase Plan; 15+ vacation days; paid holidays; paid sick time; paid parental leave; tuition assistance.
Application instructions: Not provided in the text.
Responsible for leading regulatory review of advertising, promotional, and other external communications to ensure compliance while supporting commercial objectives. Oversees product labeling development, review, and maintenance, and provides regulatory guidance throughout the Medical, Legal, and Regulatory (MLR) review process. Partners cross-functionally to support timely approval and distribution of promotional and disease state materials; primary liaison with FDA OPDP for advertising and promotional submissions; contributes to labeling strategies.
Primary Responsibilities:
- Lead development/oversight of processes and procedures for creation, review, and approval of advertising and promotional materials within the MLR process to ensure regulatory compliance.
- Review external communications, sales/marketing materials, and training for compliance with current regulations and guidance.
- Advise senior management on regulatory strategy and risk analysis tied to commercial strategy.
- Participate in training for sales and marketing on advertising/promotional materials.
- Represent the company to customers/agencies; make presentations on advertising/promotion regulatory issues.
- Other responsibilities as assigned.
Education/Experience/Skills:
- Bachelor’s degree in a scientific discipline or related field; MBA preferred.
- Targeting 10 years progressively responsible Regulatory Affairs experience focused on advertising/promotional regulations (or equivalent combination).
- Experience communicating/negotiating with OPDP and performing risk assessment.
- Experience developing/executing global regulatory strategies and assessing/communicating risk/benefit to senior management.
- Experience with labeling development and lifecycle management.
- Experience with complex negotiations with regulatory authorities; organizational and matrix management.
- Thorough knowledge of US and international pharmaceutical regulations.
- Problem-solving/conflict resolution; strong verbal/written communication; collaboration in cross-functional/global teams.
- Skilled negotiating/influencing senior leaders; creates and communicates clear team vision.
- Willing/able to travel domestically and internationally.
Benefits (as described): Discretionary bonus and equity awards; competitive base salary; medical, dental, vision; employer-paid life/disability/business travel/EAP; 401(k) with 1:1 match up to 5%; Employee Stock Purchase Plan; 15+ vacation days; paid holidays; paid sick time; paid parental leave; tuition assistance.
Application instructions: Not provided in the text.