Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology
AbbVie
4 hours ago
Remote friendly (Mettawa, IL)
United States
Corporate Functions
Senior Manager Regulatory Affairs US Advertising and Promotion – Immunology
Responsibilities:
- Capture and disseminate government, industry, and trade association activities impacting pharmaceutical regulatory policies; draft/finalize timely regulator/trade association comments.
- Represent the department in trade associations; develop relationships with trade association managers.
- Summarize findings (under supervision) in concise reports for internal distribution.
- Oversee productivity and development of regulatory staff ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies and applicable regulations/guidance.
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge across therapeutic areas.
- Ensure training and compliance with established regulations, guidance, promotional guidelines, and SOPs for advertising and promotion (for self and direct reports); manage, develop, train, and mentor staff.
- Present information to cross-functional groups.
- Deliver difficult messages to commercial organizations while maintaining relationships.
- Build and maintain relationships with management and stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
Significant Work Activity:
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.
Qualifications:
- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology/immunology, medical technology, pharmacy, pharmacology, nursing) 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.
- Management experience preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible to participate in short-term incentive programs.
Responsibilities:
- Capture and disseminate government, industry, and trade association activities impacting pharmaceutical regulatory policies; draft/finalize timely regulator/trade association comments.
- Represent the department in trade associations; develop relationships with trade association managers.
- Summarize findings (under supervision) in concise reports for internal distribution.
- Oversee productivity and development of regulatory staff ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies and applicable regulations/guidance.
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge across therapeutic areas.
- Ensure training and compliance with established regulations, guidance, promotional guidelines, and SOPs for advertising and promotion (for self and direct reports); manage, develop, train, and mentor staff.
- Present information to cross-functional groups.
- Deliver difficult messages to commercial organizations while maintaining relationships.
- Build and maintain relationships with management and stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
Significant Work Activity:
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.
Qualifications:
- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology/immunology, medical technology, pharmacy, pharmacology, nursing) 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.
- Management experience preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible to participate in short-term incentive programs.