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
- 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
$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- Moderna, Inc. is seeking a Senior Director of Regulatory Strategy to lead regulatory programs from its Cambridge headquarters or East Coast hubs... ...vaccines and to articulate clear regulatory plans across global health agencies. Ideal candidates bring extensive regulatory...Regulatory
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- 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, medical-legal-regulatory (MLR) review, and ethical...Regulatory
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- Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU, based remotely in the USA. The role partners with the Global Regulatory Lead to plan, coordinate, and deliver regulatory submissions across diverse programs...RegulatoryRemote job
- Orion Pharma in Cambridge, MA, seeks a Global Asset Lead to own the strategic vision and delivery of a priority oncology program across development, regulatory, and commercial functions. You will lead a Global Program Team, coordinate Clinical, Regulatory, CMC, Medical...Regulatory
- ...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
- Sanofi in Cambridge, MA or Morristown, NJ is seeking a Global Brand Lead for Oncology to develop and implement the global strategy for a new pipeline asset in GI and Lung cancers. You will report to the Global Franchise Head, Oncology and lead cross‑functional teams with...Geographic information system
- Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in Cambridge, MA or San Francisco, CA, you will partner cross‑functionally to ensure compliant submissions...Regulatory
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- Job Title: Associate Director, Global Regulatory Affairs Labeling Lead Location: Cambridge, MA Duration: 06 months Job Description: Leads global regulatory labeling strategy for plasma-derived therapies, including development and lifecycle management of CCDS , USPI, and...Regulatory
- ...medical innovation? As the Senior Global Medical Affairs Leader for... ...investment decisions, lead pre-launch scientific efforts... ...develops and leads bold medical strategies for MASH within the Weight Management... ...healthcare system pathways, regulatory landscapes, market access,...RegulatoryWorldwideRelocation package
- ...bioanalytical leader to design and implement robust strategies across PK, PD, and immunogenicity, supporting Oncology... ..., guide assay development with CROs, and drive regulatory interactions globally. You will lead select programs, mentor scientists, and contribute to...Regulatory
- ...seeks a Health Value Translation Lead within the PDMD function to represent the department at the Global Project Team and drive the Integrated Patient Disease Strategy across indications. You will... ...development, external engagement, and regulatory/payer #J-18808-Ljbffr BioSpaceRegulatory
- Moderna is seeking a Global Medical Lead to drive medical strategy across the Oncology portfolio, spanning early development to commercialization. You will... ...generation, governance, and external engagement with regulatory bodies, payers, and key opinion leaders. The role...Regulatory
- ...Medical Director to help shape the US medical strategy for AMR and IgAN. You will partner with US Medical, Global Medical, Clinical Development, and epidemiology... ...stakeholders and medical materials aligned to regulatory requirements. You will report to the Nephrology...Regulatory
$210.9k - $379.2k
...partners worldwide, contributing to global health initiatives. Moderna's... ...Moderna is seeking a Global Medical Lead to lead medical affairs strategy across our Oncology portfolio, spanning... ...will interface extensively with regulatory, clinical, commercial, and external...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide- ...MA seeks a Health Value Translation Lead within PDMD to represent the department at Global Project Teams and drive the Integrated Patient Disease Strategy across indications. You will ensure... ...Advocacy Groups, and contribute to regulatory and payer submissions using real‑...RegulatoryLocal area
- Job title: Global Brand Lead, Oncology Location: Cambridge, MA / Morristown, NJ About The Job Join the team transforming care... ...the development and implementation of the global strategy for a new pipeline asset in GI and Lung cancers and potential future indications. The...Geographic information systemTemporary work
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- ...seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory...Regulatory
- ..., MA (with involvement in Morristown, NJ) seeks a Global Lead for Scientific Platforms & Engagement Strategy to redefine how science is consumed in the AI era.... ...This role emphasizes cross-functional leadership, regulatory governance, and global deployment, with about 20-2...Regulatory
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