Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology
AbbVie
2 months ago
Remote friendly (Florham Park, NJ)
United States
Corporate Functions
Responsibilities:
- Proactively capture and disseminate activities of government, industry, and trade associations impacting pharmaceutical regulatory policies; draft and finalize timely comments to regulators and trade associations; distribute proposed policies to SMEs.
- Represent the department and participate in trade associations; build relationships with trade association managers.
- Summarize findings (under supervision) in concise reports for distribution within AbbVie.
- Oversee the productivity and development of regulatory staff ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies and applicable regulations/guidance (CFR, FDA guidance, PhRMA Guiding Principles, FDA/cosmetic act).
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge of government regulations across therapeutic areas.
- Ensure departmental training and compliance with regulations, guidance, promotional guidelines, and SOPs related to advertising and promotion; manage direct reports and support training/mentoring.
- Present information to cross-functional groups.
- Deliver difficult messages to commercial organizations without damaging relationships.
- Establish and maintain relationships with key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
Qualifications:
- Bachelor’s degree in science plus 7 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo).
- Preferred: PharmD plus 5 years of relevant industry experience.
- Experience in a complex, matrix environment; strong negotiation skills.
- Strong oral and written communication skills.
- Management capacity experience preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits (if explicitly stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees; eligibility for short-term incentive programs.
Application instructions:
- None stated.
- Proactively capture and disseminate activities of government, industry, and trade associations impacting pharmaceutical regulatory policies; draft and finalize timely comments to regulators and trade associations; distribute proposed policies to SMEs.
- Represent the department and participate in trade associations; build relationships with trade association managers.
- Summarize findings (under supervision) in concise reports for distribution within AbbVie.
- Oversee the productivity and development of regulatory staff ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies and applicable regulations/guidance (CFR, FDA guidance, PhRMA Guiding Principles, FDA/cosmetic act).
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge of government regulations across therapeutic areas.
- Ensure departmental training and compliance with regulations, guidance, promotional guidelines, and SOPs related to advertising and promotion; manage direct reports and support training/mentoring.
- Present information to cross-functional groups.
- Deliver difficult messages to commercial organizations without damaging relationships.
- Establish and maintain relationships with key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
Qualifications:
- Bachelor’s degree in science plus 7 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo).
- Preferred: PharmD plus 5 years of relevant industry experience.
- Experience in a complex, matrix environment; strong negotiation skills.
- Strong oral and written communication skills.
- Management capacity experience preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits (if explicitly stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees; eligibility for short-term incentive programs.
Application instructions:
- None stated.