Associate Director, Regulatory Affairs (Global) – Based in London
C&C Life Sciences are partnering with a global pharmaceutical organisation who has recently expanded its portfolio through acquisition and is now seeking an Associate Director, Regulatory Affairs to lead the global regulatory integration and Marketing Authorisation Transfer (MAT) strategy for a key acquired product.
This is a highly visible role at the centre of a global transition programme, responsible for ensuring successful transfer, maintenance, and regulatory compliance of marketing authorisations across multiple international markets, with a strong focus on UK, EU and Global frameworks.
Key Responsibilities
- Lead global Marketing Authorisation Transfer (MAT) activities for an acquired product portfolio
- Act as the primary regulatory lead supporting global integration across cross-functional teams
- Develop and execute global regulatory strategies to ensure seamless product transition post-acquisition
- Provide expert regulatory guidance across UK, EU, and international markets
- Act as the regulatory representative on global project and integration teams
- Manage submissions, variations, and lifecycle maintenance activities across multiple regions
- Assess and define regulatory strategies for CMC post-approval changes
- Engage with global health authorities, distributors, and external partners
- Ensure ongoing compliance of product labelling and regulatory documentation
- Support and mentor junior regulatory team members
Requirements
- Degree in a scientific discipline (MSc and/or RAC preferred)
- Strong background in Regulatory Affairs within pharma or biotech
- Proven experience with Marketing Authorisation Transfers (MATs) or major lifecycle projects
- Strong understanding of UK and EU regulatory frameworks
- Experience managing global or multi-region regulatory submissions
- Exposure to CMC regulatory strategy highly desirable
- Strong stakeholder management and communication skills
- Ability to operate in complex, cross-functional global environments
Reach out to Shaun@cclifesciences.com if you have any questions
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