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
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$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...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide$212k - $333.19k
...advancing a rapidly growing oncology portfolio with potentially... ...Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will... ...and ideas into actionable strategies. You will set global regulatory... ...major submissions (NDA/BLA/MAA) For the project(s) of...RegulatoryMinimum wageTemporary workLocal areaWorldwide$196.7k - $353.4k
...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape... ...Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.) The salary range for this role...RegulatoryPermanent employment$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- ...Therapeutics, Inc. in Watertown, Massachusetts is seeking a Vice President or Senior Vice President of Regulatory Affairs. This role leads global regulatory strategies for the oncology pipeline and ensures compliance with regulatory requirements. The ideal candidate should...Regulatory
$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA... ...Global Regulatory Affairs, Oncology Team, you’ll be fully accountable... ...robust global regulatory strategies for their products in... ...with preparation of sBLA, NDA, or MAA, INDs, Health Authority...Regulatory- Verastem Oncology is looking for a Senior Director of Regulatory Affairs based in Boston, MA. This role involves leading the development and implementation of the global regulatory strategy for investigational products, ensuring alignment with U.S. regulations and international...Regulatory
- Sanofi is seeking a Global Project Head, GI Oncology Leader to drive disease-area strategy across assets and guide late-stage development... ...NJ or Cambridge, MA. You will lead cross-functional clinical... ...external investigators and regulatory authorities to shape the GI #J...RegulatoryFlexible hours
- A global pharmaceutical company seeks a Regulatory Affairs Specialist in Boston, MA. The role involves developing regulatory strategies for prescription drug submissions and managing lifecycle activities. Candidates should have a Bachelor's with 5+ years in regulatory affairs...Regulatory
$193k - $210k
...pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle.... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers...Regulatory$209.35k - $258.6k
Akebia Therapeutics is seeking a Director of Regulatory Labeling in Cambridge, MA. This key role involves leading global labeling strategies across product life cycles and ensuring compliance with regulatory standards. The ideal candidate will have 10+ years of pharmaceutical...Regulatory$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Regulatory- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...Regulatory
- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...Regulatory
- Sanofi is looking for a Global Project Head to lead the clinical development strategy for solid tumor oncology compounds. This role involves managing cross-functional teams... ...stakeholders to ensure successful development and regulatory submissions. The ideal candidate will have...Regulatory
$160k - $240k
Rhythm Pharmaceuticals Inc. is seeking a Global Regulatory Lead in Boston, Massachusetts. This position involves developing regulatory strategies, leading filings, and communicating with health authorities. The ideal candidate will have over 8 years of regulatory experience...Regulatory- Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston, MA. This role involves leading global regulatory strategies for oncology programs, overseeing major submissions, and guiding cross-functional teams to deliver breakthrough treatments. The...RegulatoryWorldwide
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Strategy Associate Director responsible for overseeing global and regional regulatory strategies for development... ...pay range, potential bonuses, and market-leading benefits. #J-18808-Ljbffr Vertex PharmaceuticalsRegulatory
- 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
- AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-mediated and rare diseases. You will drive Health Authority engagements, submissions, and labeling, mentor cross...Regulatory
$196.7k - $353.4k
A leading biotechnology firm in Cambridge, Massachusetts, is seeking a seasoned regulatory leader to drive global regulatory strategy for their oncology portfolio. Responsibilities include leading regulatory submissions, health authority interactions, and developing high...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$167k - $300.7k
...infectious diseases, rare diseases, and oncology, we are seeking a Global Competitive Intelligence Lead-Oncology to lead Moderna’s commercial CI strategy across inline brands and pipeline... ...pipelines, clinical trial data, regulatory strategies, commercial activities, and...RegulatoryWork from home$178.1k - $244.86k
Job Description Objectives / Purpose Lead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle needs Drive data‑driven and technology‑enabled...RegulatoryMinimum wageTemporary workLocal areaNight shift- ...Director / Senior Director, Global Regulatory Lead Location: San... ...) Overview A growing oncology biotech is seeking a Director... ...global regulatory strategy across clinical-stage... ...leading the company’s first NDA submission and... ...regulatory lead for NDA/BLA submissions, including...RegulatoryRelocation3 days per week
- Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview... ...Strategy & Submissions Lead execution of global CMC regulatory... ...regulatory submissions (IND, IMPD, NDA, BLA, variations) Support preparation...Regulatory
- ...across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and... ...and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing...RegulatoryTemporary workWorldwide
- ...seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of Moderna’s US offices... ...technology in the US and other global markets. Responsibilities Serve as the global regulatory lead delegate for development compounds...Regulatory
- Moderna Therapeutics seeks a Global Competitive Intelligence Lead - Oncology to design and execute the oncology CI strategy across all programs globally. You will guide product positioning, scenario planning, and GTM strategies, shaping launches and lifecycle management...
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