Biogen Director, Regulatory Affairs Advertising and Promotion - Alzheimer's in Weston, Massachusetts
A. Essential Functions:
• Actively contribute to the development and implementation of regulatory strategy for promotional labeling and other communications including social media, press releases and talking points for Alzheimer's
• Regulatory lead on the Promotional Review Committee for Alzheimer's
• 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 Regulatory 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• Comment on draft guidance’s issued by FDA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
B. Additional Functions:
• 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 Sr. Director as needed.
• Minimum 8+ years pharmaceutical/Biotechnology industry experience, 6+ years regulatory advertising and promotion experience, Alzheimer's and/or Neurology experience preferred.
• Ability to work both independently with minimal direction and within teams to attain group goals.
• Demonstrate excellent communication skills.• Demonstrate effective cross-cultural awareness and capabilities.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Strong interpersonal skills and the ability to deal effectively with a variety of staff including commercial, medical, scientific, and clinical development staff.
• Knowledge and understanding of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statement related to product labeling, promotions and other communications.
• Direct experience with regulatory agencies
• Computer literate.
• Sensitivity for a multicultural/multinational environment
• Global Advertising and Promotion experience, a plus
The role is located in Weston, MA and reports into the Sr. Director Advertising and Promotion. Your 6+ years of experience in Ad/Promo will be an asset to our critical work being done in our Alzheimer's group.