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Director, Regulatory Affairs Advertising and Promotion - Alzheimer's
at Biogen
Weston, MA

Director, Regulatory Affairs Advertising and Promotion - Alzheimer's
at Biogen
Weston, MA

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Job Description

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
* 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* Comment on draft guidance's issued by FDA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

* People

* Global Advertising and Promotion experience, a plus

Additional Information

All your information will be kept confidential according to EEO guidelines.

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