Director, Regulatory Affairs Advertising & Promotion
Acadia Pharmaceuticals
July 03, 2026
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Position Summary
Responsible for leading the regulatory review of advertising, promotional, and other external communications to ensure compliance with applicable regulatory requirements. Oversees the development, review, and maintenance of product labeling 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, serves as primary liaison with the FDA’s Office of Prescription Drug Promotion (OPDP), and contributes to labeling strategies.
Primary Responsibilities
- Lead development/oversight of processes for creation, review, and approval of advertising and promotional materials to ensure regulatory compliance.
- Review external communications, sales/marketing materials (including training) for compliance with regulations and guidance.
- Advise senior management on regulatory strategy and risk analysis tied to commercial strategy and compliance.
- Participate in sales and marketing training on advertising and promotional materials.
- Represent the company to customers/agencies; make presentations on regulatory issues related to advertising and promotion.
- Other responsibilities as assigned.
Qualifications/Skills
- Bachelor’s degree in a scientific discipline (MBA preferred); 10 years progressively responsible Regulatory Affairs experience focused on advertising/promotional regulations.
- Experience communicating/negotiating with OPDP; conducting risk assessment.
- Demonstrated experience building and executing complex global regulatory strategies; assessing/communicating risk/benefit to senior management.
- Experience with labeling development and lifecycle management.
- Experience negotiating with regulatory authorities.
- Experience managing teams (matrix management).
- Thorough knowledge of US and international pharmaceutical regulations.
- Strong problem-solving/conflict resolution; excellent written/verbal communication; ability to influence policy issues.
- Excellent collaboration across cross-functional/global teams; negotiation and leadership skills.
- Willing and able to travel domestically and internationally.
Responsible for leading the regulatory review of advertising, promotional, and other external communications to ensure compliance with applicable regulatory requirements. Oversees the development, review, and maintenance of product labeling 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, serves as primary liaison with the FDA’s Office of Prescription Drug Promotion (OPDP), and contributes to labeling strategies.
Primary Responsibilities
- Lead development/oversight of processes for creation, review, and approval of advertising and promotional materials to ensure regulatory compliance.
- Review external communications, sales/marketing materials (including training) for compliance with regulations and guidance.
- Advise senior management on regulatory strategy and risk analysis tied to commercial strategy and compliance.
- Participate in sales and marketing training on advertising and promotional materials.
- Represent the company to customers/agencies; make presentations on regulatory issues related to advertising and promotion.
- Other responsibilities as assigned.
Qualifications/Skills
- Bachelor’s degree in a scientific discipline (MBA preferred); 10 years progressively responsible Regulatory Affairs experience focused on advertising/promotional regulations.
- Experience communicating/negotiating with OPDP; conducting risk assessment.
- Demonstrated experience building and executing complex global regulatory strategies; assessing/communicating risk/benefit to senior management.
- Experience with labeling development and lifecycle management.
- Experience negotiating with regulatory authorities.
- Experience managing teams (matrix management).
- Thorough knowledge of US and international pharmaceutical regulations.
- Strong problem-solving/conflict resolution; excellent written/verbal communication; ability to influence policy issues.
- Excellent collaboration across cross-functional/global teams; negotiation and leadership skills.
- Willing and able to travel domestically and internationally.