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regulatory teams * Supervise and mentor direct reports if applicable * Participate in industry groups * Comment on draft guidance's issued by FDA * Represent Ad-Promo on cross-functional teams * Actively contribute to the development and implementation of regulatory training programs for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
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
All your information will be kept confidential according to EEO guidelines.