Senior Manager Regulatory Affairs US Advertising and Promotion – US Specialty
Full-time
Salary: USD 124,500 - USD 236,500 (Yearly)
Workday Global Grade: 19
AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines. The Senior Manager combines scientific, regulatory, and business expertise to ensure products meet regulatory requirements and supports the Director in influencing the regulatory environment.
Responsibilities
Proactively capture and disseminate activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie's interests; maintain awareness of pending changes and communicate impacts; draft and finalize comments for regulators and trade associations.
Represent the department and participate in trade associations; develop relationships with trade association managers; summarize findings in concise reports for internal distribution.
Oversee the operations and development of assigned regulatory staff responsible for ensuring advertising and promotion materials are accurate, competitive, and compliant with internal policies, the Code of Federal Regulations, FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act.
Develop and guide implementation strategies for promotional activities.
Apply regulatory and technical knowledge across therapeutic areas.
Ensure departmental training and compliance with established regulations, guidance, promotional guidelines, and SOPs for advertising and promotion.
Manage direct reports (where applicable) and assist in development, training, and mentoring of staff members.
Effectively present pertinent information to cross‑functional groups and deliver difficult messages to commercial organizations without damaging relationships.
Build solid relationships with key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) to foster mutually beneficial interactions.
Work a hybrid schedule from Mettawa, IL; Florham Park, NJ, or Irvine, CA headquarters.
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 promotion).
Preferred: PharmD degree plus 5 years of relevant industry experience.
Experience working in a complex, matrix environment and strong negotiation skills.
Strong communication skills, both oral and written.
Experience in a management capacity preferred.
Experience in U.S. regulatory affairs in advertising and promotion required.
Benefits
Competitive base salary within the posted range.
Comprehensive package including paid time off (vacation, holidays, sick leave), medical/dental/vision insurance, and 401(k) for eligible employees.
Eligibility to participate in long‑term incentive programs.
Legal Notice
The compensation range described is the company’s best estimate of possible base pay, which may vary depending on location and other factors. Final compensation is subject to the company’s discretion.
Equal Employment Opportunity
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer / Veterans / Disabled.
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Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty
AbbVie · Irvine, CA, USA ·
- Pay:
- $124,500-$236,500/yr
- Job type:
- Full Time