Global Regulatory Strategy Lead - GI & Inflammation
Takeda
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- 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
Director, Global Regulatory Lead, GI & Inflammation Join to apply for the Director, Global Regulatory Lead, GI & Inflammation role at BioSpace Director... .../ Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement...RegulatoryGeographic information systemMinimum wage16 hoursFull timeTemporary workLocal areaRemote work- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams, ensure compliance with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership...RegulatoryGeographic information system
- ...Endoluminal Robotics portfolio. The senior strategic architect will unify global digital and robotic surgery strategy, drive commercialization, and lead cross-functional teams across R&D, regulatory, and clinical functions. The role emphasizes coordinating with...RegulatoryGeographic information system
- 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...RegulatoryGeographic information systemFlexible hours
$208.2k - $327.14k
Global Therapeutic Research Lead - Immunology Job Description At Takeda, we are... ...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
- A leading biopharmaceutical company is seeking a Director of Global Regulatory Strategy to lead strategies and ensure compliance with regulatory requirements. You will oversee FDA submissions, manage Global Regulatory Teams, and contribute to cross-functional projects....RegulatoryGeographic information system
$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- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...Regulatory
- 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
- Mass Digital Health is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies across its product portfolio. Based in either Morristown, NJ, or Cambridge, MA, this role is vital to ensure compliance with industry standards while advocating...Regulatory
- 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
$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- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...Regulatory
- ...(US) is seeking an Associate Director for Global Submission Management to oversee strategic global regulatory submissions across development and lifecycle... ...submissions aligned with global regulatory strategies. The role leads cross‑functional teams, manages submission...Regulatory
- A leading biotechnology firm in Boston is seeking a Regulatory Strategy Manager to oversee global regulatory activities for investigational products. This role includes preparing regulatory submissions, guiding the team on responses, and supporting NDA submissions. Ideal...Regulatory
- Beeline Medicines is seeking an Associate Director of Regulatory Strategy to lead regulatory activities for Immunology & Inflammation programs. You will steer US regulatory plans, influence international strategies with EMA, and guide IND/CTA through NDA/BLA filings, collaborating...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$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role... ...involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...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
- 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...RegulatoryWork at officeRelocation package
- 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...RegulatoryFull timeLocal areaNight shift
$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- Medella Life is looking for a Director of Regulatory Affairs to spearhead regulatory strategy for rare disease programs in Cambridge, MA. This role involves leading regulatory submissions and acting as the primary interface with health authorities like the FDA. The ideal...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
$260k - $360k
Rhythm Pharmaceuticals Inc. is seeking a Vice President of Regulatory Affairs to lead its Global Regulatory Affairs organization from Boston,... ...involves managing diverse teams, executing regulatory strategies, and ensuring high-quality outcomes in a fast-paced environment...Regulatory- Sanofi is seeking a Global Regulatory Lead to shape and execute innovative regulatory strategies for oncology products. This role interfaces with various teams to ensure compliance and strategic alignment, reporting directly to senior management. The ideal candidate will...Regulatory
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