About the role
Lead CMC regulatory activities in the late development and/or lifecycle management of GSK products.
About the responsibilities
1. Drive the CMC strategy, coordinate the preparation and review of technical (CMC) regulatory documents to support lifecycle maintenance submissions, ensuring compliance with regulatory & scientific standards and considering evolving regulatory requirements. Identify risks related to submission data and information packages, and communicate risk mitigation strategies. Play a key role in post-approval filing activities such as significant manufacturing changes or regulatory interactions.
2. Mentor or train staff, with possible direct line management responsibilities. Manage multiple complex projects and teams, providing strategic direction, data assessment, and establishing internal and external networks to navigate organizational constraints within a complex environment.
3. Engage in and potentially lead CMC Subject Matter Expert activities, both internally and externally, to enhance compliance, harmonization, and influence the regulatory environment.
4. Support major inspections (e.g., PAIs) and quality incidents (PIRCs) by delivering CMC regulatory strategies.
5. Ensure all regulatory aspects for product release are met, and submissions for lifecycle maintenance comply with regional requirements, allowing flexibility in supply, production, and quality with minimal questions.
6. Develop innovative approaches and influence processes, policies, and systems to improve departmental efficiency and quality. Play a key role in post-approval activities involving manufacturing changes or regulatory interactions.
7. Communicate complex regulatory issues across the organization and with external agencies, managing agency interactions confidently and assertively, including opposing positions when necessary.
8. Operate independently on most matters, communicating high-impact or sensitive issues promptly.
9. Participate in corporate evaluations and provide CMC regulatory support for in-licensing and divestment projects.
About you
* Master's or PhD in Life Sciences or related field.
* Extensive knowledge of drug development, manufacturing, and supply processes.
* Recognized as a CMC Regulatory expert in a specific area.
* Deep understanding of global CMC regulatory requirements and the ability to influence the regulatory environment.
* Proven project management and multi-tasking skills.
* Experience managing multiple projects and teams effectively.
* Ability to lead major post-approval filings.
* Fluency in English and French.
Preferred Qualifications & Skills
* Proven ability to influence and negotiate with regulatory agencies and industry bodies.
* Experience handling complex global CMC issues and driving continuous improvement.
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Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company dedicated to improving health through vaccines, medicines, and innovative science. We focus on immune system science and new technologies, investing in infectious diseases, HIV, respiratory/immunology, and oncology.
Our success depends on our people. We aim to create a workplace where everyone feels valued, included, and encouraged to grow, fostering wellbeing and development. Join us in our journey to get Ahead Together.
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