Associate Director, Regulatory Advertising and Promotion
Alkermes
August 15, 2026
Remote friendly (Greater Boston)
United States
Marketing
Responsibilities:
- Provide oversight and review of product and disease state education materials for consistency with approved labeling and alignment with applicable FDA regulations and guidances; provide strategic support and alternative solutions to achieve desired outcomes.
- Serve as a member of multi-disciplinary teams (Copy Clearance Committees, Global Regulatory Teams, Global Labeling Teams); chair Copy Clearance Committee.
- Maintain up-to-date knowledge of FDA laws, regulations, guidances, and the compliance environment for advertising and promotion; advise departments and participate in development of compliance procedures.
- Provide training in FDA regulations for advertising and promotion to employees and agents.
- Participate in efforts to minimize complexity of review processes.
- Build and maintain strong relationships with internal customers (Marketing, Marketing Operations, Legal, Medical).
- Serve as primary OPDP contact for assigned products; ensure timely and accurate submission of product promotional materials to FDA under Form FDA-2253.
Qualifications/Requirements:
- Bachelor’s degree in a health or science-related field and/or an advanced degree.
- Minimum 7 years Regulatory Advertising and Promotion Review experience.
Skills:
- High level of applied knowledge of applicable FDA laws, regulations, guidances, and industry standards.
- Strong understanding of clinical trial design and interpretation of clinical data.
- Strong interpersonal and written/verbal communication skills.
- Ability to shape strategies based on emerging trends.
- Ability to communicate business issues across all levels, negotiate decisions, and drive compliance solutions.
Preferred:
- Travel up to 20% may be required.
- Ability to communicate complex issues clearly and concisely.
Work model:
- Hybrid; 60% office/40% home. Onsite at Waltham, MA office at least 3 days per week; not eligible for fully remote work.
- Provide oversight and review of product and disease state education materials for consistency with approved labeling and alignment with applicable FDA regulations and guidances; provide strategic support and alternative solutions to achieve desired outcomes.
- Serve as a member of multi-disciplinary teams (Copy Clearance Committees, Global Regulatory Teams, Global Labeling Teams); chair Copy Clearance Committee.
- Maintain up-to-date knowledge of FDA laws, regulations, guidances, and the compliance environment for advertising and promotion; advise departments and participate in development of compliance procedures.
- Provide training in FDA regulations for advertising and promotion to employees and agents.
- Participate in efforts to minimize complexity of review processes.
- Build and maintain strong relationships with internal customers (Marketing, Marketing Operations, Legal, Medical).
- Serve as primary OPDP contact for assigned products; ensure timely and accurate submission of product promotional materials to FDA under Form FDA-2253.
Qualifications/Requirements:
- Bachelor’s degree in a health or science-related field and/or an advanced degree.
- Minimum 7 years Regulatory Advertising and Promotion Review experience.
Skills:
- High level of applied knowledge of applicable FDA laws, regulations, guidances, and industry standards.
- Strong understanding of clinical trial design and interpretation of clinical data.
- Strong interpersonal and written/verbal communication skills.
- Ability to shape strategies based on emerging trends.
- Ability to communicate business issues across all levels, negotiate decisions, and drive compliance solutions.
Preferred:
- Travel up to 20% may be required.
- Ability to communicate complex issues clearly and concisely.
Work model:
- Hybrid; 60% office/40% home. Onsite at Waltham, MA office at least 3 days per week; not eligible for fully remote work.