Regulatory Advertising & Promotion Strategy Director

Alkermes; Waltham (MA); On-site; USD 224,000 - 240,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Alkermes in Massachusetts seeks a Director, Regulatory Affairs, Advertising and Promotion to lead regulatory review of promotional materials and provide sound regulatory advice for Alkermes products and disease areas.

You will partner with Marketing, Medical Affairs, Sales, Legal and other teams, chair Copy Clearance Committees, and serve as primary OPDP contact for assigned products, ensuring FDA submissions and adherence to labeling requirements.

Qualifications

• Bachelor's degree in a health or science-related field and/or an advanced degree.
• Minimum of 10 years regulatory advertising and promotion review experience.
• Travel up to 20% may be required.

Responsibilities

• Provide regulatory advice related to advertising and promotion for Alkermes products and disease areas.
• Review and approve promotional materials ensuring FDA labeling compliance and alignment with regulations.
• Lead and chair Copy Clearance Committees and participate in Global Regulatory Teams.

Skills

Regulatory knowledge

Clinical trial design understanding

Strategic thinking

Communication across org levels

Education

Bachelor's degree or higher in health/science

Job description

Alkermes in Massachusetts seeks a Director, Regulatory Affairs, Advertising and Promotion to lead regulatory review of promotional materials and provide sound regulatory advice for Alkermes products and disease areas.

You will partner with Marketing, Medical Affairs, Sales, Legal and other teams, chair Copy Clearance Committees, and serve as primary OPDP contact for assigned products, ensuring FDA submissions and adherence to labeling requirements.