Manager, CMC Vaccines Mature Projects, Regulatory Affairs

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&DPosition SummaryYou will lead Chemistry, Manufacturing and Controls (CMC) regulatory activities for mature vaccine projects. You will work with regulatory, development, quality, and manufacturing colleagues to ensure compliant submissions and supply continuity. We value clear communicators who are collaborative, pragmatic, and focused on patient impact. This role offers visible influence on product lifecycle, 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:Lead CMC regulatory planning and execution for mature vaccine projects and lifecycle activities.Prepare, review and quality-check CMC content for regulatory submissions, variations, and maintenance filings.Coordinate global dossier assembly, review cycles, and responses to regulatory questions.Advise cross-functional teams on regional regulatory requirements and their impact on project timelines.Support supply continuity by ensuring regulatory requirements for manufacturing, release and distribution are in place.Contribute CMC subject matter expertise and share best practices to improve regulatory processes.Why You?Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goalsBachelor’s degree in pharmacy, chemistry, biotechnology or related scientific discipline, or equivalent experience.2+ years’ experience in CMC regulatory affairs or pharmaceutical/biopharmaceutical development with direct involvement in regulatory submissions.Experience preparing or contributing to lifecycle submissions and post-approval regulatory activities.Knowledge of CMC requirements for vaccines or biologics and of regulatory dossier formats.Prior experience working with cross-functional teams including quality, manufacturing, and clinical development.Preferred QualificationIf you have the following characteristics, it would be a plusMaster's or PhD degree in a relevant scientific or regulatory field.Direct experience with vaccine development or biologics CMC regulatory strategy.Experience managing global submissions and interactions with major regulatory agencies.Experience supporting inspections and providing regulatory input for manufacturing or process changes.Familiarity with regulatory requirements across major regions such as the United States and European Union.Track record of driving process improvements or efficiencies in regulatory operations.Strong written and verbal communication skills with attention to detail.#LI-GSKIf 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - View email address on click.appcast.io 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #J-18808-Ljbffr GlaxoSmithKline