Global Regulatory Lead - Oncology NDA/BLA Strategy
Meet Life Sciences
Meet Life Sciences is seeking a Director / Senior Director, Global Regulatory Lead in Boston, MA to drive regulatory strategy across oncology programs. The ideal candidate will lead NDA submissions and collaborate with various teams, leveraging over 10 years of regulatory affairs experience. The role offers a hybrid work model, requiring 3 days in the office each week, with relocation support provided. A Bachelor’s degree is essential, with a preference for advanced degrees and oncology experience. #J-18808-Ljbffr Meet Life Sciences
$177k - $278.08k
...advancing a rapidly growing oncology portfolio with potentially... ...Join Takeda as a Director, Global Regulatory Lead Oncology where you will be... ...will set global regulatory strategy and lead major submissions... ...including major submissions (NDA/BLA/MAA)For the project(s) of responsibility...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$177k - $278.08k
Job Description Director, Global Regulatory Lead Oncology - responsible for setting global regulatory strategy and leading major submissions for high‑impact oncology programs... .... Ensure all submission types (NDA/BLA/MAA) are executed on time with high quality....RegulatoryTemporary workLocal areaRemote work$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...and overall program milestones. Lead IND and CTA, NDA and BLA submissions, regulatory planning and submission of...RegulatoryLocal areaFlexible hours2 days per week$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape... ...certificationDelivery of at least one major application (NDA/BLA/MAA/JNDA etc.)Acts with urgency and...RegulatoryPermanent employmentFull timeWork at officeWork from home$167k - $300.7k
...seeking a Director of Regulatory Strategy to support select programs... ...rare, autoimmune and oncology portfolios. This is a... ...leader within Global Regulatory Science, responsible... ...as global regulatory lead accountable for all... ...one major application (NDA/BLA/MAA/JNDA etc.) Ability...RegulatoryPermanent employmentWork at officeWork from home- ...Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role reports to the... ...and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions with health authorities worldwide...RegulatoryWorldwide
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$193k - $210k
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$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma... ...and global regulatory submissions, ensuring... ...regulatory submissions (NDA/BLA/MAA). This role combines... ...programs, ensuring document strategy aligns with clinical,... .... Experience in oncology, rare disease, or other...RegulatoryWorldwide- A leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience in regulatory... ...to ensure alignment between US and global strategies. Exceptional...Regulatory
$167k - $300.7k
The Role Global Competitive Intelligence Lead‑Oncology - responsible for developing and executing Moderna’s competitive intelligence strategy across oncology, guiding product positioning, scenario... ..., clinical trial data, regulatory strategies, commercial activities...Regulatory- ...therapeutic areas including immunology, oncology and neuroscience - and products... ...Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is... ...Area and supports manager and/or Global Regulatory Lead (GRL) in the development...RegulatoryLocal area
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$177k - $278.08k
...will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory CMC strategy and leads the execution of regulatory... ...preparing the CMC aspects of global registrational submissions of a... ...- including preparation of NDA/BLA/MAA. Equivalent industry experience...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- Job title : Global Lead, Scientific Platforms & Engagement Strategy Location: Cambridge, MA, Morristown, NJ About The Job At Sanofi, we chase the miracles... ...scientific platforms and AI‑generated content meet regulatory, MLR review, and ethical standards applicable to...Regulatory
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