Role Overview
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.
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.
* Lead, coach, and mentor junior team members, fostering a high-performing and collaborative team environment.
Key Competencies
* 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)