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/maintain effective communication with Medical, Marketing, Regulatory, Legal, and Public Affairs; identify process/policy improvements, develop recommendations/plans, and lead initiatives.
- Assist in departmental budget management; identify and communicate budgetary needs to Operations and Finance; project current and future expenditures and business needs.
- Operate independently; recognize when to consult senior leadership; in absence of Director, manage day-to-day operations and departmental initiatives impacting internal/external customers.
- Encourage innovation; hold employees accountable; recognize, mentor, reward, and recommend promotions based on performance and development.
- Demonstrate understanding of regulations and regulatory authority guidance, political/legal climate, and industry practices for advertising and promotions.
- Develop/implement complex processes and projects; develop and deliver strategic presentations for senior management.
Qualifications:
- Bachelorβs degree.
- 8+ years relevant experience in pharma/medical devices/biologics (or 6+ years with an advanced degree).
- Experience in US Regulatory Affairs Advertising and Promotion.
- Experience developing and implementing successful global regulatory strategies.
Preferred:
- Advanced degree (MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD).
- Experience in a management capacity.
Required Skills:
- Experience in a complex, matrix environment.
- Strong oral and written communication.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for short-term incentive programs.