Senior Manager CMC Vaccines Mature Products

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 authors, as needed, of technical (CMC) regulatory documents to support lifecycle maintenance submissions, in accordance with applicable regulatory & scientific standards, considering evolving regulatory requirements.

Identify risks to the business associated with submission data and information packages, and communicate well-defined risk mitigation strategies. Play a key role in major post-approval filing activities (e.g., significant manufacturing changes or key regulatory interactions in lifecycle management).

Mentor or train staff, with potential direct line management responsibilities. Manage project activities for multiple complex projects and teams, providing strategic direction and understanding departmental constraints within a highly complex organization.

Engage and potentially lead CMC Subject Matter Expert activities, with deep/specialized expertise, both internally (for compliance, harmonization, efficiency) and externally (advocacy, shaping regulatory environment).

Support major inspections (e.g., PAIs) or quality incidents (PIRCs) by delivering CMC regulatory strategies.

Accountable for submission content, advising on regulations, guidelines, procedures, and policies related to development, registration, and manufacturing of biopharmaceutical products to expedite approvals.

Ensure all CMC regulatory aspects for product release are in place to maintain market supply, and that submissions meet regional requirements, allowing maximum flexibility with minimal questions.

Innovate and improve CMC regulatory processes, policies, and systems to enhance efficiency and quality. Play a key role in post-approval activities involving significant manufacturing changes or regulatory interactions.

Communicate complex regulatory issues across the company and with external agencies to influence project and policy decisions, managing agency interactions confidently.

Operate independently on most matters, communicating sensitive issues promptly and appropriately.

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 ability to influence the regulatory environment.

Proven project management and multi-tasking skills.

Experience managing multiple projects and teams.

Ability to lead major post-approval filings and regulatory interactions.

Fluency in English and French.

Preferred Qualifications & Skills

Strong project management and multitasking capabilities.

Effective influencing and negotiating skills with regulatory agencies and industry bodies.

Ability to handle complex global CMC issues through change and 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, focusing on infectious diseases, HIV, respiratory/immunology, and oncology.

Our success depends on our people. We strive to be an inspiring, inclusive environment where everyone 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. Be cautious of bogus job ads or emails asking for payments; always verify communications are from official GSK channels.

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