Regulatory Manager, Delivery – CMC RA

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About the role

You will lead and coordinate delivery of CMC (Chemistry, Manufacturing and Controls) regulatory activities to support timely submissions and lifecycle management of . You will work closely with regulatory colleagues, quality, supply chain, external partners and project teams. We value clear communication, practical problem solving, collaboration, and a growth mindset. This role offers strong learning and career growth, the chance to shape regulatory strategy, and meaningful impact in delivering safe, high-quality medicines aligned with GSK’s mission of uniting science, technology and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Lead planning, coordination and delivery of complex CMC submissions and post-approval changes across multiple products and markets across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards. ​ • Manage multiple variation projects simultaneously, including source document review for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers). • Coordinate cross-functional inputs from quality, supply chain, manufacturing, and external partners to create submission-ready documentation. • Track project timelines, identify risks, and implement mitigation actions to meet regulatory milestones. • Respond to questions from health authorities and support regulatory negotiations and interactions. • Serve as Subject Matter Expert (SME)  for CMC Regulatory Affairs, mentoring and guiding team members,  while sharing best-practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions. Drive improvements to regulatory processes, tools and templates and share best practices across teams. Why You? This role is hybrid. You will be expected to work from our GSK office minimum 2 days per week. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Bachelor’s degree in pharmacy, chemistry, biochemistry, biotechnology, biology or a related life science. • At least 8 years’ experience in regulatory affairs or CMC delivery within the pharmaceutical or biotech industry. • Practical experience authoring CTD Module 3 (Quality) content and handling post-approval variations. • Strong project coordination skills with experience managing multiple stakeholders in a matrix environment. • Clear written and spoken English and strong interpersonal communication skills. • Track record of delivering to deadlines with attention to detail and quality. Preferred Qualification If you have the following characteristics, it would be a plus: • Master’s degree or higher in a relevant scientific discipline. • Experience with global submissions for Vaccines and familiarity with EU and US regulatory processes. • Experience responding to health authority questions and managing regulatory interactions. • Knowledge of change control, GMP interfaces and quality systems as they relate to CMC. • Experience with regulatory document management systems or regulatory information tools. • Demonstrated ability to drive process improvements or participate in digital transformation projects. What we offer: • Established job in an international, well-known pharmaceutical company. • Opportunity to work in professional team playing crucial role in maintaining GSK portfo

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