Global Regulatory Strategy Lead - GI & Inflammation
Takeda Pharmaceuticals
A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience in the pharmaceutical industry with a strong background in regulatory affairs. You will lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives aligned with business goals. The role offers an executive-level position with competitive compensation. #J-18808-Ljbffr Takeda
$174.5k - $274.23k
A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams, and ensuring compliance with FDA regulations. Candidates should have over 8 years of pharmaceutical...RegulatoryGeographic information system$154.4k - $242.55k
...you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge... ...of translational biomarker strategies across preclinical and... ...Team (TST) and partners with GI-DDU research, physician scientists... ...documents submitted to Regulatory Agencies.• Establish and...RegulatoryGeographic information systemMinimum wageTemporary workLocal area- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that... ...and compliance programs Implement compliance strategies and processes Prepare, review, and approve regulatory...RegulatoryGeographic information systemFull timeLocal area
$174.5k - $274.23k
...application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides...RegulatoryGeographic information systemMinimum wageFull timeTemporary workLocal areaRemote work$208.2k - $327.14k
...Global Therapeutic Research Lead - Immunology Job Description At Takeda... ...Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team.... ...Gastroenterology and Inflammation TA strategy and treatment paradigm... ...industry, including regulatory requirements and...RegulatoryGeographic information systemFull timeTemporary workFor contractorsLocal areaRemote workWorldwide- Beeline Medicines in Boston is seeking a Director of Regulatory Strategy to lead the global regulatory strategies for early-stage and pipeline programs in the immune and inflammation (I&I) therapeutic area. The role requires at least 10 years of regulatory experience, focusing...Regulatory
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus on...RegulatoryLocal areaFlexible hours2 days per week$178.1k - $244.86k
...PURPOSELead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle... ...access globallyACCOUNTABILITIES Lead end-to-end strategy development and execution...RegulatoryMinimum wageTemporary workLocal areaNight shift- ...status quo for the better. Chiesi Global Rare DiseasesChiesi Global Rare... ...the Head of Access Marketing, Strategy, & US HEOR for the Americas, this role will lead the development and implementation... ...Review Committee (Legal/Medical/Regulatory) and experience with VeevaVault...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
$193k - $210k
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- Sanofi Inc. is seeking a Global Brand Lead for Transplant (Solid Organ Transplant) based in the... ...senior role leads the end-to-end SOT strategy, P&L, and market execution, collaborating... ...Affairs, Market Access, Digital, Regulatory and regional teams to drive global growth...Regulatory
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$100k - $143k
Relaytherapeutics in Cambridge, Massachusetts is looking for a motivated regulatory professional to join their regulatory team. In this role, you will support the development and execution of regulatory strategies for a transformative pipeline, contributing to IND, CTA, NDA,...Regulatory- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...Regulatory
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- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...Regulatory
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- Moderna is seeking an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC... ...product lifecycles, develop global CMC strategies, and guide product teams in preparing agency... ...and regulatory applications. The role leads interactions with health authorities, manages...Regulatory
- Moderna seeks a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early development through commercialization.... ...and cross-functional alignment, interfacing with regulatory, clinical, and commercial functions. The successful...Regulatory
- ...in Cambridge, Massachusetts, is seeking a dedicated leader for their global quality control (QC) function. The role involves overseeing external QC laboratories and ensuring compliance with regulatory standards while providing strategic oversight in both clinical and commercial...Regulatory
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- Ipsen Group in the United States seeks a Global Brand Lead to shape and deliver the global brand strategy for an asset portfolio, aligning global and regional teams... ..., and influence across Medical, Market Access, Regulatory, and Supply Chain functions. The ideal candidate...Regulatory
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