Regulatory Project Manager

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture that is ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together.

You will lead regulatory projects for Vaccines portfolio that support product lifecycle activities across markets. You will work closely with regulatory affairs, clinical, quality, supply and external partners. We value clear communicators who manage risks, plan effectively, and build strong relationships. This role offers visible impact, professional growth and a chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.

• Drive strategy for CMC regulatory submissions. Coordinate timely preparation and author CMC complex technical regulatory dossiers to support applications for marketing authorisation, lifecycle activities and maintenance of registered pharmaceutical and vaccine products in accordance with applicable regulations and scientific standards.
• Identify risks associated with submission data and information packages. Ensure adequate contribution and lead CMC regulatory discussions during interactions with regulatory authorities worldwide.
• Contribute to creation, maintenance and continuous improvement of CMC regulatory processes, policies, instructions and systems.
• Serve as mentor/trainer for new team members.
• Act as subject‑matter expert.
• Act as technical dossier approver.
• Ensure adequate interaction and partnership with the Global Regulatory Lead’s team, GSC, QA, LOCs and ESQ to define proper regulatory CMC filing strategy.

• Independently assess, manage, and/or drive the CMC strategy; coordinate timely preparation and author multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with applicable regulatory and scientific standards.
• Understand the internal and external regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in‑licensing and divestment projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC.
• Ensure adequate interaction and partnership with senior stakeholders (leadership team) to define proper regulatory CMC filing strategy, demonstrating flexibleritu­pling continuous improvement while maintaining customer focus.
• Ensure adequate contribution during interactions with worldwide regulatory 돈관 authorities. Author responses to regulatory agency questions.
• Understand regulations, guidelines, procedures and policies ibuater concerning registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best‑practices and learnings within the CMC regulatory teams and other impacted functions.
• Mentor and/or train staff; develop subject‑matter experts within the team by providing guidance and relevant knowledge.
• Identify risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.
• Contribute to, and lead (as required) the creation, maintenance and continuous improvement of CMC regulatory processes, work instructions, policies and systems. Ensure information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.
• Communicate, through the appropriate teams, complex regulatory issues…