Strategy Lead, CMC Mature, Regulatory Affairs

Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects for vaccines. You will manage CMC regulatory activities mainly in the U.S. across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross‑functional teams to ensure compliance and drive 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 to submit to regulatory authorities mainly for the U.S., including the FDA, to support lifecycle management of established vaccines. Provide regulatory advice to cross‑functional teams, including R&D, manufacturing, and quality assurance to ensure compliance with U.S. regulatory requirements, including Good Manufacturing Practices (GMPs). 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, as well as to lead discussions in formal meetings and other engagements with the Agency. 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 Module3. 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. Salary & Benefits If you’re based in Cambridge, MA; Waltham, MA; Rockville, MD; or SanFrancisco, CA, the annual base salary for new hires in this position ranges $113,850 to $189,750. This position also offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Working Model This role is hybrid. You will be expected to be on‑site regularly and collaborate with colleagues across sites and regions. Equal Opportunity Employer 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