Regulatory Affairs Director

Colorado State University, Health Network; Marlow; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an experienced professional for the role of International Regulatory Affairs Manager. The successful candidate will lead a team responsible for ensuring compliance in advertising and promotion across international markets. This opportunity requires a strong background in regional regulations, excellent leadership skills, and a commitment to innovation and quality.

Qualifications

• 7-10 years of pharmaceutical experience with 5 years in advertising/promotion regulatory.
• Strong management experience in a complex environment.
• Solid understanding of UK and International Codes of Practices.

Responsibilities

• Manage a team responsible for International regulatory advertising.
• Provide input into brand strategy and manage risk assessment.
• Lead operations for the International Regulatory Affairs Advertising team.

Skills

Leadership

Communication

Problem Solving

Education

Bachelor's Degree in Science

Master's or Ph.D.

Job description

ICompany 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 strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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). 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

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.htmlI