Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology
AbbVie
2 months ago
Remote friendly (Irvine, CA)
United States
Corporate Functions
Responsibilities:
- Proactively monitor 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; highlight key points clearly and concisely.
- Represent the department and participate in trade associations as needed; build relationships with trade association managers.
- Summarize findings (under supervision) in concise reports for internal distribution.
- Oversee operations productivity and development of regulatory staff responsible for ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies and applicable regulations (CFR, FDA guidance, PhRMA Guiding Principles, FDA and cosmetic act).
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge broadly across therapeutic areas.
- Ensure departmental training and compliance for advertising and promotion regulations; manage direct reports and support development, training, and mentoring.
- Present information to cross-functional groups.
- Deliver difficult messages to commercial organizations without damaging relationships.
- Build relationships with key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
Qualifications:
- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology/immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) 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 experience preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.
Significant Work Activity:
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.
- Proactively monitor 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; highlight key points clearly and concisely.
- Represent the department and participate in trade associations as needed; build relationships with trade association managers.
- Summarize findings (under supervision) in concise reports for internal distribution.
- Oversee operations productivity and development of regulatory staff responsible for ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies and applicable regulations (CFR, FDA guidance, PhRMA Guiding Principles, FDA and cosmetic act).
- Develop and guide implementation strategies for promotional activities.
- Apply regulatory/technical knowledge broadly across therapeutic areas.
- Ensure departmental training and compliance for advertising and promotion regulations; manage direct reports and support development, training, and mentoring.
- Present information to cross-functional groups.
- Deliver difficult messages to commercial organizations without damaging relationships.
- Build relationships with key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.).
Qualifications:
- Minimum: Bachelor’s degree in science (biology, chemistry, microbiology/immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) 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 experience preferred.
- Experience in US Regulatory Affairs Advertising and Promotion.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.
Significant Work Activity:
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.