Associate Director, Regulatory Affairs US Advertising and Promotion
Responsibilities:
- Set strategy and lead cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives; make operational decisions (workflow, assignments, staff development) with minimal direction.
- Maintain and evaluate productivity metrics to project current and future business needs.
- Align and maintain communication channels with Medical, Marketing, Regulatory, Legal, and Public Affairs; identify process/policy improvements, develop recommendations/plans, and lead initiatives.
- Assist with departmental budget management; identify and communicate budgetary needs to Operations and Finance; project current and future expenditures and business needs.
- Operate independently; consult senior leadership as needed for risks. In absence of Director, manage day-to-day operations.
- Encourage innovation; hold employees accountable for goals; recognize, mentor, reward, and recommend promotions based on performance, results, and development.
- Apply knowledge of regulations and regulatory authority guidance, political/legal climate, and industry practices related to advertising and promotions.
- Develop and implement complex processes/projects; develop and deliver strategic presentations for senior management.
Qualifications:
Minimum:
- Bachelorβs degree.
- 8+ years relevant experience (e.g., pharmaceutical/medical devices/biologics; pharmacy rotations/Public Health) or 6+ years with an advanced degree.
- Experience in US Regulatory Affairs Advertising and Promotion.
- Experience developing and implementing successful global regulatory strategies.