Regulatory Submission Lead

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. Position Summary You will lead planning, compilation and delivery of regulatory registration requirements for investigational and lifecycle activities globally. You will work closely with global submission teams, clinical, CMC, quality, publishing and local regulatory partners. We value organized, collaborative people who communicate clearly, solve problems practically, and focus on delivering high‑quality submissions on time. This role offers visible impact on patient access, strong growth opportunities, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together. Responsibilities Plan, compile and deliver complete regulatory registration requirements for submission dossiers (electronic and paper) on agreed timelines. Coordinate and track requirements and cross‑functional inputs from clinical, CMC, quality and safety colleagues. Coordinate and manage Certificates of Pharmaceutical Product (CPPs), as well as notarization and legalization activities in support of global submissions. Maintain Regulatory information management system, submission trackers, version control and milestone plans to ensure transparency and audit readiness. Identify and implement process improvements, coach colleagues and share best practice. Basic Qualifications Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline, or equivalent experience. 3+ years of experience in regulatory affairs, submission management, publishing or lifecycle maintenance within the pharmaceutical or clinical research environment. Experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities. Experience interacting with Health Authorities, particularly the US FDA. Preferred Qualifications Experience with regulatory content or information management systems such as Veeva Vault or similar platforms. Experience with Labeling, CMC content and Module 1 preparation for submissions. Knowledge of CPP processes and legalization/notarization requirements. Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices. Experience preparing responses to authority questions and supporting regulatory meetings. Experience working in a global, matrix environment and coordinating third‑party vendors, with the ability to interpret complex regulatory. Prior experience leading small project teams or serving as single point of contact for submissions. Professional certification in regulatory affairs, Notary or related field. Proven ability to manage third‑party vendors and external partners. Strong written and verbal communication skills with the ability to present clear stakeholder updates. Strong organizational skills, attention to detail and proven ability to manage competing priorities under deadlines. Strong compliance mindset with high attention to detail. Good digital proficiency. Work Arrangement This position is hybrid in the United States. Expect a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager. Equal Employment Opportunity Statement 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