Regulatory Affairs 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 ambitious for patients, accountable for impact, and committed to doing the right thing, accelerating significant assets that meet patients’ needs and have the highest probability of success. We unite science, technology, and talent to get ahead of disease together. Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working with cross‑functional teams across development, manufacturing, quality and regulatory to prepare submissions and respond to regulatory requests. Your work will directly support timely access to medicines and continued supply for patients. We value clear communicators, pragmatic problem solvers, and collaborative colleagues who enjoy influencing technical and regulatory decisions. Responsibilities Drive the CMC strategy, coordinate timely preparation and authorship of technical (CMC) regulatory documents to support lifecycle maintenance submission content, ensuring compliance with applicable regulatory and scientific standards. Identify risks to the business associated with submission data and information packages and develop well‑defined risk mitigation strategies. Mentor or train staff; may have direct line management responsibility. Manage project activities for multiple complex projects and teams simultaneously, including reporting staff as appropriate. Engage and lead CMC Subject Matter Expert activities internally and externally to improve compliance, harmonization and efficiency. Deliver CMC regulatory strategy to support major inspections or quality incidents. Provide accountability for submission content and advise on regulations, guidelines, procedures and policies related to development, registration and manufacturing of biopharmaceutical products. Ensure all appropriate CMC regulatory aspects for product release are in place, maintaining continuity of market supply and meeting regional requirements for lifecycle maintenance submissions. Formulate novel approaches and influence personnel to evaluate and improve CMC regulatory processes, policies and systems. Communicate complex regulatory issues independently across the company and with external agencies and third parties, ensuring alignment with business needs. Operate with considerable independence, promptly communicating sensitive matters or those with high business impact. Participate in corporate evaluation and provide CMC regulatory support/advice to in‑licensing and divestment projects. Basic Qualification Bachelor’s degree in life sciences, pharmacy, chemistry, engineering or related field. 6+ years of CMC regulatory experience in pharmaceutical, biologic, device or combination product development. Experience preparing and contributing to regulatory submissions (CTD modules, amendments, INDs, BLAs/NDAs or equivalents). Experience with GMP and manufacturing processes and their relation to regulatory submissions. Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. Experience handling complex global CMC issues through continuous change and improvement. Experience in major post‑approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management). Preferred Qualification Advanced degree (Master’s or PhD) in a relevant scientific discipline. Direct experience leading interactions with U.S. FDA or other global regulatory agencies. Experience managing multiple complex projects or supervising small teams. Experience with eCTD submissions and regulatory submission tools. Prior experience supporting inspections, regulatory audits or major filing activities. Demonstrated ability to influence stakeholders and drive regulatory solutions in a matrix environment. Experience working in cross‑functional teams and providing clear regulatory advice to technical colleagues. Proven project management and multi‑tasking skills. Ability to manage and direct multiple projects/teams. Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues. Experience in life‑cycle management, ideally with previous roles within pharmaceutical and/or vaccines marketed product support. Continued professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies. Identified as CMC Regulatory expert in a specific subject area. Highly developed interpersonal, presentation and communication skills with established internal and external networks. Proven experience supervising and training junior staff and the ability to motivate and lead others. Work Arrangement This position is hybrid in the United States. Expect a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Benefits The position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program. Additional benefits include health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal Opportunity Employer. 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, military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr