Senior Manager Regulatory Affairs US Advertising and Promotion β Immunology
Responsibilities:
- Proactively track and disseminate activities of government, industry, and trade associations impacting pharmaceutical regulatory policies; draft/finalize regulator and trade association comments.
- Represent the department in trade associations; maintain relationships with trade association managers.
- Summarize findings in concise internal reports.
- Oversee productivity and development of regulatory staff responsible for accurate, competitive, compliant advertising and promotion materials per CFR, FDA guidance, PhRMA Guiding Principles, and FDA/cosmetic act.
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge across therapeutic areas.
- Ensure departmental training and compliance with advertising/promotion regulations, guidance, promotional guidelines, and SOPs; manage, develop, train, and mentor direct reports.
- Present key information to cross-functional teams; deliver difficult messages to commercial organizations without harming relationships.
- Build relationships with stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
- Hybrid schedule: 3 days in office, 2 days remote from Lake County, IL; Florham Park, NJ; or Irvine, CA.
Qualifications:
- Bachelorβs degree in science plus 7 years relevant industry experience (regulatory affairs fellowship/Health Authority/ad promo, etc.).
- Preferred: PharmD plus 5 years relevant industry experience.
- Experience in complex matrix environment; strong negotiation skills.
- Strong oral and written communication.
- Management capacity preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible to participate in long-term incentive programs.