BioSpace is hiring: Senior Manager Regulatory Affairs US Advertis...
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Overview
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Dermatology
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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We aim to impact people's lives across therapeutic areas such as immunology, oncology, neuroscience, and eye care, including products in our Allergan Aesthetics portfolio. For more information about AbbVie, visit www.abbvie.com. Follow us on social media: @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.
Job Description
The Senior Manager Regulatory Affairs US Advertising and Promotion in Immunology-Dermatology combines scientific, regulatory, and business expertise to ensure products meet legislation. The role involves developing and supervising regulatory professionals, supporting regulatory environment influence, and acting as a subject matter expert (SME). The individual shares knowledge, analyzes regulatory changes, and supports team activities.
Responsibilities
- Monitor and communicate regulatory policy changes impacting AbbVie, drafting comments for regulators and trade associations, and highlighting key points.
- Represent the department in trade associations and develop relationships with managers.
- Summarize findings in concise reports for internal distribution.
- Oversee regulatory staff responsible for advertising and promotional materials compliance with CFR, FDA guidance, PhRMA principles, and the FDA and Cosmetic Acts.
- Develop strategies for promotional activities and ensure departmental training and compliance with regulations and SOPs.
- Present information effectively to cross-functional groups and manage relationships with stakeholders across departments.
Qualifications
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing) with 7+ years of relevant experience; PharmD with 5+ years preferred.
- Experience in complex, matrix environments with strong negotiation and communication skills.
- Management experience and specific US regulatory affairs advertising and promotion experience preferred.
Additional Information
The compensation range is estimated based on the job grade and may vary by location. We offer comprehensive benefits, including paid time off, insurance, 401(k), and participation in incentive programs. Pay amounts are contingent upon various factors and are at the company's discretion.
AbbVie is an equal opportunity employer committed to diversity and inclusion. For more details, visit here. Applicants seeking accommodations can find more information here.
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