Manager, Global Regulatory Affairs, Oncology
$138.75k - $231.25kWomen In Bio
Global Regulatory Affairs Manager Develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. Collaborate with cross‑functional teams to shape development plans and regulatory interactions across multiple regions. 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 life cycle. 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. Compensation & Benefits Annual Base Salary: For candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $138,750 to $231,250. The US salary ranges account for location, skills, experience, education, and market rates. This position also 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 employees and families, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal Opportunity Employer. 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 other basis prohibited under federal, state, or local law. #J-18808-Ljbffr Women In Bio
$138.75k - $231.25k
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...SuggestedLocal area$222k - $370k
...the development of appropriate regulatory strategies and execution for... ...Accountable to the Global Regulatory Strategy TG Head and... ...Significant experience in regulatory affairs (10+ years) ~5 + years... ...Knowledge and experience in Oncology TA, preferably with ADC and lung...SuggestedLocal area- GlaxoSmithKline (GSK) is seeking a Regulatory Affairs Specialist in Durham, NC, to develop and deliver regulatory strategies aligned with market... ...of relevant drug development experience, particularly in oncology. GSK offers competitive salaries, bonuses, and comprehensive...Suggested
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