Manager, Global Regulatory Affairs, Oncology

Global Regulatory Affairs Manager – GSK As a Global Regulatory Affairs Manager at GSK, you will develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. You will collaborate with cross‑functional teams and stakeholders in multiple regions. Key Responsibilities Work closely with the Global Regulatory Lead, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements. Collaborate with cross‑functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan. Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval. Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision‑making. Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle. Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes. Basic Qualifications & Skills Bachelor’s degree in biological or healthcare science. 1+ year of experience in the drug development process within regulatory affairs, preferably oncology. 1+ year of experience in clinical trial requirements in at least one major regional or global market. Preferred Qualifications & Skills Advanced scientific degree (PhD, MD, PharmD). Proven ability in managing global and regional development, submission, and approval activities. Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints. Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation. Strong written and verbal communication skills for clarity and impact. Experience working effectively in matrix teams. Location: individuals based in Cambridge, MA, Waltham, MA, Rockville, MD, or San Francisco, CA are eligible for the listed salary range. Benefits Annual base salary ranges $138,750 to $231,250 depending on location and experience. Annual bonus and eligibility for share‑based long‑term incentive program. Health care and other insurance benefits for employee and family. Retirement benefits. Paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer 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, military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr GSK