Strategy Lead, CMC Mature, Regulatory Affairs

We are a global biopharma company with bold ambitions to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on vaccines and medicines, leveraging advanced science and technology to deliver life‑changing solutions. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects. The role focuses on U.S. regulatory activities across development, registration and lifecycle management, collaborating closely with cross‑functional teams. The position offers visible influence on product life cycles and professional growth. Responsibilities Develop and implement CMC regulatory strategies 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 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. regulations, including GMPs. Serve as the main U.S. point of contact for the FDA, responding to general inquiries, notifications, and requests for information; 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 continuous improvement. Basic Qualification Bachelor’s degree in life sciences, pharmacy, chemistry, or related field (advanced degree preferred). 2+ years of CMC regulatory affairs experience in the U.S., focusing on IND and BLA submissions to FDA. Experience as a U.S. liaison for FDA communications. CMC experience for biologics, including regulatory requirements and technical content for submissions. Comprehensive understanding of FDA regulations (21 CFR, ICH guidelines, GMP/GDP for biologics). Experience with global CMC regulatory requirements and drug development processes. Experience reviewing and preparing CMC submission components, particularly eCTD Module 3. Experience with biologics manufacturing processes: formulation, quality control, analytical methods. Ability to translate technical/scientific information into clear regulatory submissions. Experience with mature product lifecycle management and post‑approval changes. Preferred Qualification 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 deadlines. Proven ability to manage multiple projects while maintaining compliance. Strong attention to detail to ensure accuracy and completeness of CMC documentation. Proactive in identifying and resolving gaps or inconsistencies in regulatory submissions. Collaboration skills with cross‑functional teams (quality, manufacturing, clinical development). Excellent written and verbal communication. Working Model This role is hybrid. You will be expected to work on‑site regularly and collaborate with colleagues across sites and regions. Compensation and Benefits If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $113,850 to $189,750, adjusted for location, skills, experience and market rate. The position also includes an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care, retirement plans, paid holidays, vacation, paid caregiver/parental and medical leave. We provide accommodations for applicants who require assistance. For accommodation requests, please contact us at View email address on click.appcast.io. 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. GSK does not accept referrals from employment businesses or agencies for the vacancies posted on this site. All referrals must be authorized in writing by GSK's procurement/Human Resources department before submission. #J-18808-Ljbffr GSK