Associate Director, Regulatory Affairs US Advertising and Promotion
Responsibilities:
- Set strategy and lead cross-functional, multidisciplinary therapeutic teams and multidivisional initiatives.
- Make decisions and plans for operations (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 and lead initiatives.
- Assist with departmental budget management; identify and communicate budgetary needs, and project current and future expenditures.
- Operate independently; consult senior leadership as needed for risks; in absence of Director, manage day-to-day operations.
- Encourage innovation; hold employees accountable; recognize/mentor/reward and recommend promotions based on performance and development.
- Apply regulatory guidance and regulations related to advertising and promotions.
- Develop/implement complex processes and projects; deliver strategic presentations for senior management.
Qualifications:
- Bachelorβs degree.
- 8+ years relevant experience (e.g., pharma/medical devices/biologics experience, public health pharmacy rotations) OR 6+ years with an advanced degree.
- Experience in US Regulatory Affairs Advertising and Promotion.
- Experience developing and implementing successful global regulatory strategies.
Preferred Qualifications:
- Advanced degree (MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD).
- Experience in a management capacity.
Other Required Skills:
- Experience working in a complex, matrix environment.
- Strong oral and written communication skills.