Global Regulatory Lead, Oncology Strategy & Submissions
$270k - $330kIpsen Biopharmaceuticals Inc.
Ipsen Biopharmaceuticals Inc. is looking for a Senior Director of Global Regulatory Affairs specializing in Oncology. This critical role demands extensive regulatory leadership to manage programs, ensuring compliance and strategic alignment with global development objectives. The successful candidate will have a minimum of 15 years in Regulatory Affairs, strong communication skills, and a proven track record with global regulatory authorities. A competitive salary ranging from $270,000 to $330,000 is offered, along with comprehensive benefits including 401(k) contributions and medical coverage. #J-18808-Ljbffr
- Job title: Global Regulatory Strategist Location: Morristown, NJ/ Cambridge, MA... ...developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development... ...remit, as needed Regulatory Submissions & Operations Leads submission...RegulatoryLocal area
$153.6k - $241.34k
...A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston...Regulatory$196.8k - $295.2k
...Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Director in Boston, MA. In this role, you will lead the development and implementation of global regulatory strategies for assigned projects. The successful candidate will have a Bachelor's degree in Biology...Regulatory- Sanofi is seeking a Global Submission Lead to manage regulatory submission activities for new global products. The role involves project management, ensuring compliance with regulatory standards, and leading cross-functional teams in a dynamic environment. The ideal candidate...Regulatory
$159k - $195k
...A leading biotechnology firm in Waltham, MA is seeking an Associate Director of Regulatory Chemistry Manufacturing and Control (CMC). This role involves executing global regulatory strategies and partnering with various teams to support clinical registration and commercial...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... ...background in regulatory submissions. The position is based in...Regulatory- ...are advancing a rapidly growing oncology portfolio with potentially first‑... ...worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...you will set global regulatory strategy and lead major submissions for high‑impact oncology programs...RegulatoryLocal areaWorldwide
- ...Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires extensive... .... Key responsibilities include leading regulatory submissions and health authority interactions, anticipating...Regulatory
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development... ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory$208.2k - $327.14k
...advancing a rapidly growing oncology portfolio with potentially... ...as a Senior Director, Global Regulatory Lead – Oncology, where you will... ...and ideas into actionable strategies. You will set global regulatory... .... Accountable for US FDA submissions and approvals of project(s...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- ...Global Submission Lead As Global Submission Lead within our R&D team, you will be responsible... ...planning, coordination, and tracking of regulatory priority portfolio and integration... ...companies for implementation of e-submission strategies between two companies. Ensure that...RegulatoryWorldwideFlexible hours
$196.7k - $353.4k
...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 regulatory... ...commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and...RegulatoryPermanent employment- Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the role As Global Submission... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...companies for e‑Submission strategies. Coordinate with Regulatory Operations...RegulatoryWorldwide
$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA About... ...Global Regulatory Affairs, Oncology Team, you’ll be fully... ...and robust global regulatory strategies for their products in Sanofi... ...Project Strategy (GRPS), Global Submission Strategy, and core product...RegulatoryFull time- ...A leading biopharmaceutical company is seeking an Associate Director for Global Regulatory Affairs in Boston. This role involves leading regulatory strategies for complex projects, ensuring compliance with global regulations, and serving as the primary FDA contact. The...Regulatory
- ...member of Takeda Oncology, your work will contribute... .... As part of the Global Medical Affairs... ...Group Lead, Solid Tumors. About... ...scientific communications strategy and deliverables,... ..., NCCN or pathway submissions, animations,... .... Compliance and Regulatory - excellent understanding...RegulatoryFor contractorsWork experience placementFreelanceLocal area
- ...A leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic regulatory leadership for... ..., and overseeing global regulatory strategies. The ideal candidate will have over 15 years...Regulatory
$177k - $278.08k
...JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Regulatory$169.4k - $266.2k
...member of Takeda Oncology, your work will contribute... .... As part of the Global Medical Affairs... ...Group Lead, Solid Tumors. As... ...scientific communication strategy and deliverables,... ..., NCCN or pathway submissions, animations, and digital... .... Compliance and Regulatory: Excellent...RegulatoryMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- ...Allergan is seeking a Senior Director Regulatory Affairs Therapeutic Area Head in Cambridge, MA. This leadership role involves managing global regulatory strategies and supervising a team of global regulatory leads. Applicants should have over 10 years of experience in...Regulatory
- ...A leading biotech company based in Boston is looking for a Director... ...to oversee the execution of global oncology clinical studies. This role requires... ...You will manage operational strategies, vendor oversight, and ensure compliance with regulatory standards. Competitive...Regulatory
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
- ...company, is the leading clinical‑stage biopharmaceutical... ...team includes globally recognized... ...program strategy and coordinate execution... ...and/or immune‑oncology program(s). The Global... ...Operations, Regulatory, CMC, PK/PD, Safety... ...documents and submissions, including INDs,...Regulatory
$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...RegulatoryFlexible hours- Sanofi is seeking a Global Labeling Strategist to shape the development and implementation of global labeling strategies for products in clinical development. You will collaborate... ...with cross-functional teams, providing regulatory guidance and ensuring alignment between...Regulatory
$99.2k - $165.4k
JOB SUMMARY The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides... ...and execution of Pfizer Oncology’s regulatory strategies... ...support to Pfizer Oncology’s Global Regulatory Strategy Teams... ...and organizational goals. Lead or co-lead projects, effectively...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$154.4k - $242.55k
...future for the world. As a global, values‑based... ...Global Risk Financing Strategy and ensuring alignment... ...overall group strategy. Lead specific Global Insurance... ...of underwriting submissions and support any market... ...business challenges and/or regulatory issues; recommend...RegulatoryMinimum wageFull timeContract workTemporary workWork at officeLocal areaImmediate start$174.5k - $274.23k
...A global leader in oncology is seeking a Director for its Patient Value Access team in Boston. This role involves developing strategies for optimal pricing and market access, conducting payer research, and collaborating across teams. Ideal candidates will have substantial...- ...Scorpion Therapeutics in Cambridge, Massachusetts is seeking a leader in Global Regulatory Affairs CMC to oversee regulatory strategy and submissions for small molecules and biologics. The ideal candidate should have over 20 years of experience in the industry and a strong...Regulatory
- ...Therapeutics, Inc. seeks an Associate Director for Global Regulatory Affairs Marketed Products in Boston, MA. You will lead global regulatory strategies, advise teams on compliance, and ensure timely project submissions to the FDA. The ideal candidate has extensive...Regulatory
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