Associate Director, Regulatory Advertising and Promotions

Biogen SANDBOX • Weston, MA

4d

About The Position

The Associate Director, Regulatory Affairs Advertising and Promotion will actively contribute to the development and implementation of regulatory strategy for promotional labeling and other communications for Biogen's portfolio. They will coordinate all aspects of AP regulatory submissions including promotional materials and pre-use submissions for subpart E&H products as needed. Successful hire will also represent US Ad-Promo on global regulatory teams.

Requirements

• Minimum 6+ years pharmaceutical/Biotechnology industry experience, 4+ years regulatory advertising and promotion experience.
• Ability to work both independently with minimal direction and within teams to attain group goals.
• Demonstrate excellent co

Responsibilities

• Actively contribute to the development and implementation of regulatory strategy for promotional labeling and other communications including social media, press releases and talking points
• Regulatory lead on the Promotional Review Committee for assigned products
• Coordinate all aspects of AP regulatory submissions including promotional materials and pre-use submissions for subpart E&H products as needed
• Provide regulatory representation to early stage programs, including review of DSMR materials as needed
• Prepare and deliver effective presentations for external and internal audiences.
• Represent US Ad-Promo on global regulatory teams
• Supervise and mentor direct reports if applicable
• Participate in industry groups
• Comment on draft guidance’s issued by FDA
• Represent Ad-Promo on cross-functional teams
• Actively contribute to the development and implementation of regulatory training programs for cross-functional partners
• Contribute to organizational effectiveness.
• Maintains optimism and energy in the face of change and adversity.
• Effectively serve as a role model within regulatory and cross-functionally.
• Ability to impact industry and agency organizations.
• Ability to step in for Director as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees