Strategy Lead, CMC Mature, Regulatory Affairs

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 ambitious for patients, accountable for impact, and committed to doing the right thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the U.S. across development, registration, and lifecycle management. Collaboration with cross‑functional teams ensures compliance and drives innovation. Responsibilities Develop and implement CMC regulatory strategies mainly in the U.S. for vaccines, ensuring compliance with FDA expectations and global standards. Prepare and review technical regulatory documents for U.S. authorities, including the FDA, to support lifecycle management of established vaccines. Provide regulatory advice to cross‑functional teams (R&D, manufacturing, quality assurance) to ensure compliance with U.S. regulatory requirements, including GMP. Serve as point of contact mainly in the U.S. for the FDA to receive and respond to general inquiries, notifications, and requests for information, and to lead discussions in formal meetings and other engagements. Identify risks and propose mitigation strategies to ensure smooth regulatory processes. Mentor and train team members, fostering a culture of continuous improvement. Basic Qualifications Bachelor's degree in life sciences, pharmacy, chemistry, or a related field (advanced degree preferred). 2+ years of experience in CMC regulatory affairs mainly in the U.S., with a focus on IND and BLA submissions to the FDA. Experience as a liaison in the U.S. for FDA communications. CMC experience for biologics, including regulatory requirements and technical content for submissions. Comprehensive understanding of FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics. Experience with global CMC regulatory requirements and drug development processes. Experience with reviewing and preparing CMC submission components, particularly eCTD Module 3. Experience with manufacturing processes for biologics, including formulation, quality control, and analytical methods. Experience translating technical and scientific information into clear, concise regulatory submissions. Experience with mature product lifecycle management and post‑approval changes. Preferred Qualifications Master's degree or PhD in a relevant scientific discipline. Regulatory Affairs Certification (e.g., RAPS). Experience leading teams and managing complex regulatory submissions. Track record of effective negotiation with regulatory agencies. Strong organizational skills to manage multiple CMC submissions and meet strict deadlines. Proven ability to manage multiple projects while maintaining compliance with regulatory requirements. Strong attention to detail to ensure accuracy and completeness of CMC documentation. Ability to identify and resolve gaps or inconsistencies in regulatory submissions proactively. Proven ability to collaborate with cross‑functional teams including quality, manufacturing, and clinical development. Strong written and verbal communication skills. Working Model This role is hybrid. Employees are expected to be on‑site regularly and collaborate with colleagues across sites and regions. Equal Opportunity 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. #J-18808-Ljbffr GlaxoSmithKline