Associate Director Regulatory Affairs

We are seeking an experienced and strategic Associate Director, Regulatory Affairs to lead complex regulatory activities and provide expert guidance across global cross‑functional teams. This role is critical in shaping regulatory strategy, ensuring compliance, and driving successful product lifecycle management across multiple markets, with a strong focus on the UK and EU.

Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.Key Responsibilities

• Lead and oversee Marketing Authorisation Transfer activities (MATs), providing strategic regulatory direction to global cross‑functional teams.
• Interpret and apply global regulatory requirements (with emphasis on UK/EU regulations), ensuring alignment and informed decision‑making across the organisation.
• Serve as the regulatory lead on multidisciplinary project teams, influencing strategy and ensuring regulatory considerations are embedded in all stages of product development and lifecycle management.
• Develop and drive execution of Regulatory Strategy Documents (RSDs) in line with business objectives and global market requirements.
• Maintain deep, current knowledge of regulatory frameworks, guidelines, SOPs, and industry best practices.
• Lead interactions with global regulatory authorities, distributors, and external partners as required.
• Provide strategic oversight on post‑approval CMC changes, defining and executing appropriate global filing strategies.
• Direct the preparation, review, and submission of high‑quality regulatory documentation, including electronic submissions where applicable.
• Oversee lifecycle management of regulatory filings and ensure the integrity of centralised documentation systems.
• Ensure global compliance of product labelling, working closely with cross‑functional stakeholders.
• Establish and maintain robust regulatory records, databases, and health authority communications.
• Drive regulatory compliance in document review processes and change management activities.
• Monitor regulatory developments and proactively communicate risks, opportunities, and strategic insights to stakeholders. xwzovoh
• Lead, coach, and mentor junior team members, fostering a high‑performing and collaborative team environment.
• Strategic thinker with strong analytical and decision‑making capabilities
• Exceptional leadership and stakeholder management skills
• Excellent written and verbal communication, with the ability to influence at all levels
• Strong problem‑solving skills with the ability to develop and present multiple solutions
• Highly collaborative, with a customer‑focused and professional approach
• Proactive, driven, and results‑oriented
• High level of integrity and confidentiality
• Proven ability to coach, mentor, and develop talent

Education & Experience

• Bachelor’s degree (BSc) in a scientific or related discipline (required)
• Master’s degree (MSc) and/or RAC certification (preferred)
• Significant experience in global regulatory affairs, including UK, EU, US, and international markets
• Strong expertise in UK/EU regulatory requirements
• Experience with advertising and promotional regulations (highly desirable)

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