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Manager, Global Regulatory Affairs, Oncology

$138.75k - $231.25k

GlaxoSmithKline

Location: USA – Pennsylvania (Upper Providence) – Durham Blackwell Street, USA – Maryland (Rockville), USA – Massachusetts (Waltham) Key Responsibilities Work closely with GRL, 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+ years experience in the drug development process within regulatory affairs, preferably oncology. 1+ years of experience in clinical trial requirements in at least one major regional/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. Annual base salary ranges from $138,750 to $231,250 based on location. The position offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. 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

Vacancy posted 4 days ago
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