Senior CMC Regulatory Strategy Manager

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 directly supports timely access to medicines and continued supply for patients. Responsibilities Drive the CMC strategy and coordinate the timely preparation and authorship of technical (CMC) regulatory documents for lifecycle maintenance submissions. Identify risks to the business associated with submission data and information packages and communicate 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. Provide strategic direction, data assessment and conclusions within and across departments. Engage and lead CMC subject‑matter‑expert activities, both internally (for compliance, harmonization and efficiency) and externally (advocacy and shaping the regulatory environment). Deliver CMC regulatory strategy to support major inspections or quality incidents. Ensure submission content meets regulatory and scientific standards and that all appropriate regulatory aspects for product release are in place. Formulate novel approaches and influence people, evaluating and improving CMC regulatory processes, policies and systems. Communicate complex regulatory issues independently across the company and with external agencies as necessary. Participate in corporate evaluation and provide CMC regulatory support/advice to in‑licensing and divestment projects. Basic Qualifications 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. Preferred Qualifications 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. Support 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 multitasking skills. Track record of effective influencing and negotiating with regulatory agencies, industry bodies and internal colleagues. Life‑cycle management experience including roles within pharmaceutical and/or vaccine product support. Continued professional growth in global regulatory affairs including communication of emerging trends and policies. Identified opportunities to further educate internal colleagues and formulate approaches to new requirements. Identified as a CMC regulatory expert in a specific subject area. Highly developed interpersonal, presentation and communication skills. Proven experience supervising and training junior staff. Benefits Hybrid work arrangement; mix of in‑office days and remote days. Competitive base salary range (U.S. $144,375–$240,625) with annual bonus and long‑term incentive program. Health care and other insurance benefits for employees and families. Retirement benefits, paid holidays, vacation and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal Opportunity Employer. Employment is based on merit and is not influenced by race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any other basis prohibited under law. #J-18808-Ljbffr