Strategy Lead, CMC Mature, Regulatory Affairs

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. Find out more: Our approach to R&D Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments. This role offers visible influence on product life cycles, opportunities for professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with FDA expectations and global standards. Prepare and review technical regulatory documents to submit to regulatory authorities, 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 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. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field (advanced degree preferred). 2+ years of experience in CMC regulatory affairs, with a focus on IND and BLA submissions to the FDA. Experience as a liaison for FDA communications. CMC experience for biologics, including regulatory requirements and technical content for submissions. Comprehensive understanding FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics. Experience global CMC regulatory requirements and drug development processes. Experience with reviewing and preparing CMC submission components, particularly eCTD Module 3 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 Qualification If you have the following characteristics, it would be a plus. 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. Working model This role is hybrid. You will be expected to be on-site regularly and collaborate with colleagues across sites and regions. #GSK-LI • If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $113,850 to $189,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.