AbbVie · 20 hours ago
Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology
AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Manager of Regulatory Affairs for US Advertising and Promotion in Immunology is responsible for ensuring compliance with regulatory legislation and leading a team of regulatory professionals while influencing the regulatory environment.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner
Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers
Summarizes findings, under supervision, in concise reports for distribution within AbbVie
Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act
Development and guides implementation strategies for promotional activities
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas
Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
Effectively presents pertinent information to appropriate cross-functional groups
Effectively delivers difficult messages to commercial organizations without damage to relationships
Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange
Qualification
Required
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, etc.)
Experience working in a complex and matrix environment and exhibits strong negotiation skills
Strong communication skills, both oral and written
Preferred
PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
Experience in management capacity preferred
Experience in US Regulatory Affairs Advertising and Promotion preferred
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Recent News
2026-01-09
2026-01-08
Morningstar.com
2026-01-08
Company data provided by crunchbase