Senior CMC Regulatory Strategy 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, 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. Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work 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. These responsibilities include some of the following: Drive the CMC strategy, coordinate the timely preparation and authorship of technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with applicable regulatory & scientific standards, and taking into account evolving regulatory requirements. Identify risks to the business associated with submission data and information packages and provide and communicate well‑defined risk mitigation strategies. Mentor or train staff and may have direct line management responsibility. Manage project activities for multiple complex projects and teams simultaneously, including reporting staff. Provide strategic direction, data assessment, and conclusions within and across departments. Establish organizational networks (internal and external) while understanding departmental constraints within a highly complex organization. Engage and may lead CMC subject‑matter‑expert activities, both internally (for increased compliance, harmonization and efficiency) and externally (advocacy and shaping the regulatory environment). Deliver CMC regulatory strategy to support major inspections (e.g., PAI's) or quality incidents (PIRCs). Hold accountability for submission content; understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products to expedite submission, review and approval of global CMC applications. Ensure all appropriate CMC regulatory aspects for product release are in place, ensuring continuity of market supply. Ensure information submitted in lifecycle maintenance submissions meets regional requirements, allowing maximum supply/production/quality flexibility with minimal unanticipated questions. Formulate novel approaches and influence people, evaluating and improving CMC regulatory processes, policies and systems to enhance efficiency and quality of departmental work. Directly and independently communicate complex regulatory issues across the company and with external agencies and third parties as necessary, to influence project and policy issues aligned with business needs, ensuring the optimum position for the company. Operate with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicate sensitive matters or those with potential for high business impact. Participate in corporate evaluation and provide CMC regulatory support or advice to in‑licensing and divestment projects. Why You? This role offers the opportunity to lead key activities and progress your career in a dynamic, patient‑focused environment. 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 how they relate 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 in a variety of settings. Life‑cycle management experience ideally including previous roles within pharmaceutical and/or vaccine‑marketed product support. Continued professional growth in global regulatory affairs, including communication of evolving/emerging trends and policies. Identified opportunities to further educate internal colleagues and formulate approaches to meet new requirements. 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 in supervising and training junior staff within an organization and has the ability to motivate and lead others. Work arrangement This position is hybrid in the United States, with a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Annual base salary for this role ranges from $144,375 to $240,625 in selected U.S. locations. Offers are typically within the advertised range. 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact us at View email address on click.appcast.io. #J-18808-Ljbffr NCBiotech