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GSK
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Job Reference:
5aa05cda1a9d
Job Views:
3
Posted:
08.07.2025
Expiry Date:
22.08.2025
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Job Description:
About the role
Lead CMC regulatory activities in the late development and/or lifecycle management of GSK products.
About the responsibilities
Drive the CMC strategy, coordinate the timely preparation and authorship of technical (CMC) regulatory documents to support lifecycle maintenance submissions, in accordance with applicable regulatory and scientific standards, considering evolving regulatory requirements. Identify risks related to submission data and information packages, and communicate well-defined risk mitigation strategies. Play a key role in major post-approval filing activities such as significant manufacturing changes or key regulatory interactions in lifecycle management.
Mentor or train staff, with possible direct line management responsibilities. Manage project activities for multiple complex projects and teams, providing strategic direction, data assessment, and cross-departmental conclusions. Establish internal and external organizational networks to understand departmental constraints within a highly complex organization.
Engage and lead CMC Subject Matter Expert activities, possessing deep expertise internally and externally to enhance compliance, harmonization, and efficiency. Support major inspections and quality incidents, and ensure all CMC regulatory aspects for product release are in place to maintain market supply. Ensure lifecycle submissions meet regional requirements to maximize supply, production, and quality flexibility.
Innovate and improve CMC regulatory processes, policies, and systems to boost departmental efficiency and quality. Manage agency interactions effectively, advocating and shaping the regulatory environment, and communicating complex issues independently across the company and with external agencies to align with business needs.
Operate independently on most matters, communicating sensitive or high-impact issues promptly. 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 a 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, with proven ability to influence the regulatory environment worldwide.
Strong project management and multi-tasking skills, with a track record of managing multiple projects and teams. Fluency in English and French. Proven negotiating skills with regulatory agencies and industry bodies. Demonstrated capability to handle complex global CMC issues through ongoing change and improvement.
Why GSK?
GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease. We focus on vaccines, specialty, and general medicines, emphasizing the immune system and innovative data technologies across core therapeutic areas. Our success depends on our people, and we strive to be an inspiring, inclusive environment where employees can thrive, grow, and contribute to our mission.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment agencies without prior written approval. Agencies must obtain authorization from GSK's HR department before referring candidates. Unauthorized actions will be considered performed without GSK's consent.
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