Regulatory Manager, Delivery - Licence Maintenance

As Regulatory Manager, Delivery – Licence Maintenance, you will lead the efficient delivery and high quality of CMC (Chemistry, Manufacturing, and Controls) regulatory outputs and licence maintenance activities across GSK’s product portfolios. You will oversee the authoring, review and approval of complex CMC submissions and market-specific requirements, guide cross-functional teams to secure timely regulatory approvals and lifecycle management, and proactively manage risks to achieve optimal regulatory outcomes aligned with GSK’s business objectives. You will also help drive continuous improvement and digital transformation of CMC regulatory processes, strengthening regulatory capabilities and developing subject matter expertise within the team.

We value clear communication, strong digital and data skills, practical problem solving, collaboration and a growth mindset. This role offers the opportunity to shape how we deliver CMC regulatory strategy and licence maintenance globally, while developing yourself and others.

• →Lead the execution of CMC regulatory strategy for licence maintenance across GSK portfolios by overseeing the authoring, review and approval of high-quality CMC submissions and variations, including market-specific requirements.
• →Ensure efficient delivery and high quality of CMC outputs and that effective regulatory processes are followed to assess and assure the quality, reliability and consistency of data used in regulatory submissions.
• →Independently manage multiple complex CMC project assignments simultaneously, including planning, tracking and reporting against key milestones and regulatory timelines.
• →Coordinate cross-functional inputs from CMC Regulatory Affairs, Global Supply Chain, local operating companies, quality, manufacturing and external partners to produce submission-ready documentation and smooth delivery of CMC projects.
• →Prepare, analyze data and author complex CMC technical regulatory documents to support marketing authorizations, lifecycle activities and maintenance of registered products.
• →Understand and apply regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications.
• →Identify risks associated with submission data and information packages, influence people, systems and processes, and propose alternative approaches; escalate matters that affect corporate or agency policies as appropriate.
• →Drive continuous improvement for defined and new CMC regulatory processes, including leading or contributing to digital transformation and process-automation initiatives across CMC Regulatory Affairs.
• →Champion the adoption of digital tools, RIM systems, dashboards, structured data tools and AI-supported workflows to improve CMC submission quality, efficiency and data stewardship practices.
• →Strengthen CMC regulatory capabilities by mentoring and/or training staff, developing subject matter experts and guiding teams in using digital tools and data-driven approaches.
• →Maintain appropriate organizational networks and partnerships with key stakeholders (e.g. CMC RA stakeholders, GSC, LOCs, senior leadership) and contribute to interactions with worldwide regulatory authorities as needed.
• →Track, analyze and report on team performance against key performance indicators using digital dashboards and performance analytics, ensuring digital best practices and accuracy of structured regulatory data across global submissions.
• →Provide CMC regulatory support and advice to in-licensing, divestment projects and R&D teams, as required.

This role is hybrid. You will be expected to work from the office at least two days per week.

• Master’s degree or higher in a relevant scientific discipline (life sciences or related field).
• Experience leading or significantly contributing to digital transformation and process-automation initiatives within CMC Regulatory Affairs.
• Experience interacting with worldwide regulatory authorities and supporting in-licensing and divestment projects or R&D teams.
• Demonstrated ability to influence and negotiate with stakeholders in a variety of settings and to shape the internal/external regulatory environment.
• Experience tracking and reporting performance using digital dashboards and performance analytics, with a focus on structured regulatory data quality.
• People management experience, including recruitment, coaching, training and development, and serving as a point of escalation for team members and stakeholders (where applicable to the specific posting level).

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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