* 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regulatory teams * Supervise and mentor direct reports if applicable * Participate in industry groups * Comment on draft guidance's issued by FDA * Represent Ad-Promo on cross-functional teams * Actively contribute to the development and implementation of regulatory training programs for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
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 Director as needed.
* 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 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 manufacturing 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