Regulatory Affairs Manager Advertising and Promotion
Company Description
About AbbVie
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 strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube
Job Description
Responsibilities
• Provides International regulatory position, perspective, and expertise related to advertising and promotion to internal and external customers/business partners. Maintains current knowledge of international codes of practice, regulations and guidance that impacts pharmaceutical advertising and promotion.
• Collaborates and communicates effectively through all levels of management across multiple functions (Commercial, Medical, Legal, and Compliance) and with external faculty/ key opinion leaders. Recognized by organizational counterparts as a key company resource on pharmaceutical advertising and
promotion. Applies novel and creative methods to problem solving. Constantly searches for out of the box solutions while maintaining quality and adherence to regulations. Balances business needs and risk assessments with creative decision-making abilities, balancing innovation with risk.
• Has accountability for the sound representation of International Regulatory Advertising and Promotion position within and external to Allergan Aesthetics. Defines boundaries of accepted risk tolerance within assigned programs.
• Maintains current knowledge of international codes of practice, regulations and guidance. Demonstrates compliance with international codes of practice relevant regulations and provides input into brand strategy and key asset and therapy area initiatives, as required.
• Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate) and competitive landscape (e.g. product strategies, commercial messages, positioning, etc.). Provides functional input on key initiatives impacting other areas. Leads the implementation of risk management strategies and risk management plans for International advertising and promotion activities.
• Lead operations, initiatives, and strategies for the International Regulatory Affairs Advertising and Promotion team.
• Share best practice and contribute to the development of marketing campaigns from concept creation and through execution in collaboration with crossfunctional partners.
• Provide guidance on International codes to affiliate markets as and when required and when required and confidently present competitive landscape cases to encourage team learning
• Supports departmental and business strategies, quality initiatives, compliance
with policies and procedures, and the implementation of improvement plans.
Contributes to the evaluation of departmental needs and implements solutions
to enhance and facilitate operations.
Qualifications
Preferred 7-10 years of pharmaceutical experience with a minimum of 5 years direct advertising and promotion regulatory experience
• Minimum Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required. Master’s or Ph.D. preferred. Registered medical practitioner or pharmacist in the UK preferred.
• Registered signatory or successful completion of Abbvie qualifications to become a registered signatory preferred.
• The candidate must have a solid understanding of advertising and promotion regulations and UK and International Codes of Practices, having had direct responsibility in this area.
• Strong stakeholder management skills and multi-disciplinary team management. Proven 3-5 years in a leadership role preferred
• Strong communication skills, both oral and written, clear decision-making authority, experience handling compressed timelines.
• Experience with products at different stages of the life cycle
• Experience working in a complex and matrix environment
Additional Information
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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