Hybrid Associate Director, Regulatory Advertising & Promotion

Alkermes; Boston (MA); Hybrid; USD 185,000 - 197,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Alkermes in Boston is seeking an Associate Director of Regulatory Affairs, Advertising and Promotion who will provide regulatory advice on communications for Alkermes products and disease areas. The role collaborates with Marketing, Medical Affairs, Sales and Legal to support initiatives and review promotional materials.

Hybrid work arrangement requires 60% office presence with at least 3 days/week on site at MA office.

Qualifications

• Bachelor’s degree in health or science field; advanced degree preferred.
• Minimum of 7 years regulatory advertising and promotion review experience.
• High level of knowledge of FDA laws, regulations, and guidances.
• Strong interpersonal and communication skills (written and verbal).
• Ability to shape regulatory strategies based on emerging trends.

Responsibilities

• Oversee and review education materials for consistency with labeling and FDA guidance.
• Chair Copy Clearance Committee and participate in cross-functional teams.
• Maintain up-to-date knowledge of FDA laws and advise departments to ensure compliance.
• Provide training on FDA regulations for advertising and promotion to employees.
• Participate in efforts to minimize complexity of review processes.
• Build and maintain strong relationships with internal customers including Marketing, Legal, and Medical.
• Serve as primary contact for OPDP for assigned products and submit materials to the FDA under Form FDA-2253.

Skills

FDA regulations knowledge

Clinical trial interpretation

Interpersonal communication

Strategic thinking

Cross-functional collaboration

Education

Bachelor's degree in health/science

Advanced degree

Job description

Alkermes in Boston is seeking an Associate Director of Regulatory Affairs, Advertising and Promotion who will provide regulatory advice on communications for Alkermes products and disease areas. The role collaborates with Marketing, Medical Affairs, Sales and Legal to support initiatives and review promotional materials.

Hybrid work arrangement requires 60% office presence with at least 3 days/week on site at MA office.