Job description
Site Name: Belgium-Wavre, GSK HQ, India - Karnataka - Vemgal Bangalore Site, Italy - Siena, Rixensart, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence, Warsaw
Posted Date: Jun 24 2025
About the role
Lead CMC regulatory activities in the late development and/or lifecycle management of GSK products.
Responsibilities
* Drive the CMC strategy, coordinate the timely preparation and review of technical (CMC) regulatory documents supporting lifecycle maintenance submissions, ensuring compliance with regulatory and scientific standards.
* Identify risks related to submission data and information packages; develop and communicate risk mitigation strategies.
* Play a key role in post-approval activities such as significant manufacturing changes or regulatory interactions.
* Mentor or train staff; manage project activities for multiple complex projects and teams.
* Engage and lead CMC Subject Matter Expert activities, influencing internal and external regulatory environments.
* Support major inspections and quality incidents with regulatory strategies.
* Ensure regulatory compliance for product release and lifecycle maintenance submissions.
* Innovate and improve CMC regulatory processes, policies, and systems.
* Manage complex regulatory issues, communicate with agencies, and influence project and policy decisions.
* Operate independently on regulatory matters, communicating sensitive issues promptly.
* Support corporate evaluations and in-licensing/divestment projects with CMC regulatory expertise.
About you
* Master's or PhD in Life Sciences or related field.
* Deep knowledge of drug development, manufacturing, and supply processes.
* Recognition as a CMC Regulatory expert in a specific area.
* Comprehensive understanding of global CMC regulatory requirements.
* Proven project management and multi-tasking skills.
* Experience managing multiple projects and teams.
* Fluency in English and French.
Preferred Qualifications & Skills
* Effective influencing and negotiation skills with regulatory agencies.
* Ability to handle complex global CMC issues through change and improvement.
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Why GSK?
GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease and improve health worldwide. We focus on vaccines, specialty, and general medicines, investing in core therapeutic areas like infectious diseases, HIV, respiratory/immunology, and oncology.
Our success depends on our people. We aim to create an inclusive environment where everyone can thrive, grow, and feel valued. Join us in our journey to get Ahead Together.
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