Regulatory Affairs Director

TN United Kingdom; Marlow; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a seasoned professional in regulatory affairs to lead their International Advertising and Promotion team. This role involves managing compliance with international advertising regulations, collaborating across multiple functions, and mentoring future leaders in the field. The ideal candidate will bring extensive experience in pharmaceutical advertising, strong management skills, and a creative approach to problem-solving. This is an exciting opportunity to contribute to innovative marketing strategies while ensuring adherence to regulatory standards in a dynamic environment.

Qualifications

• 7-10 years of pharmaceutical experience with direct advertising and promotion regulatory experience.
• Solid understanding of advertising and promotion regulations and UK and International Codes of Practices.

Responsibilities

• Provide international regulatory expertise related to advertising and promotion.
• Manage a team ensuring compliant advertising strategies for marketed compounds.
• Lead operations and strategies for the Regulatory Affairs Advertising and Promotion team.

Skills

Pharmaceutical Advertising Regulations

Creative Problem Solving

Team Management

Communication Skills

Risk Management

Education

Bachelor's Degree in Science

Master's or Ph.D. in Science

Job description

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• 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 guidancethat impacts pharmaceutical advertising and promotion.
• Collaborates and communicates effectively through all levels of management across multiple functions (Commercial, Medical, Legal, and Compliance). 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.
• Manages a team of material reviewers and final signatories responsible for ensuring compliant International marketed and development compounds advertising and promotion strategies. 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 manages financial business goals. Provide 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 cross-functional 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.
• Creates an environment to attract, retain, empower and mentor future leaders across Regulatory Advertising and Promotion.

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 guidancethat impacts pharmaceutical advertising and promotion.
• Collaborates and communicates effectively through all levels of management across multiple functions (Commercial, Medical, Legal, and Compliance). 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.
• Manages a team of material reviewers and final signatories responsible for ensuring compliant International marketed and development compounds advertising and promotion strategies. 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 manages financial business goals. Provide 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 cross-functional 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.
• Creates an environment to attract, retain, empower and mentor future leaders across Regulatory Advertising and Promotion.

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 management skills and multi-disciplinary team management. Proven 3-5 years in a leadership role preferred
• Experience with products at different stages of the life-cycle
• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written

Additional Information

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