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
$154.4k - $242.55k
...as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge... ...translational biomarker strategies across preclinical and clinical... ...(TST) and partners with GI-DDU research, physician... ...and documents submitted to Regulatory Agencies.• Establish and maintain...RegulatoryGeographic information systemMinimum wageLocal 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
$177k - $278.08k
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 strategic and tactical advice to teams to achieve timely and...RegulatoryGeographic information systemMinimum wageFull timeLocal areaRemote workWorldwide- Takeda in Boston, MA seeks a Director of Regulatory Strategy to define and lead global regulatory strategies for complex programs, collaborating cross-functionally to ensure compliance and timely submissions. The role leads GRTs, coordinates health authority interactions...RegulatoryGeographic information system
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- ...senior leader to design and execute translational biomarker strategies, partnering with GI-DDU researchers to identify and validate targeted pathways... ...for mechanism of action and drug response. The role leads the Translational Sub‑Team, drives biomarker endpoints for...Geographic information system
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- ...content, educational resources, and congress activities within a global cross-functional team. The role emphasizes digital and AI-... ...planning, content creation, and stakeholder engagement while ensuring regulatory compliance and effective risk #J-18808-Ljbffr Takeda...Regulatory
$148.5k - $214.5k
Job title: Global Scientific Communications Lead, Immunology PipelineLocation: Morristown, NJAbout the JobThe... ...execution of scientific communications strategies and plans for the gastroenterology... ...plans in conjunction with the Resp/GI Sci. Comm and Medical and Early Development...Geographic information systemFull timeWork at officeFlexible hours3 days per week- Sanofi is seeking a Global HCP Marketing Lead to shape and execute the HCP marketing strategy for duvakitug in IBD, from prelaunch through launch and beyond. You will... ...record in KOL engagement, advisory boards, and regulatory-compliant materials. #J-18808-Ljbffr BioSpaceRegulatoryGeographic information system
$177k - $278.08k
...RoleIn this role, you will help shape the global commercial strategy for an investigational therapy in... ...developments, treatment changes, regulatory pathways, and potential commercialization... ...skills.Demonstrated ability to lead globally across functions, work independently...RegulatoryMinimum wageLocal area$177k - $278.08k
...member of the R&D Procurement team, leading category strategy and a team of category managers to maximize... ...support business objectives, regulatory requirements, quality standards, and... ...and advantageBehavioral:As members of Global Procurement, you are expected to demonstrate...RegulatoryMinimum wageContract workLocal area- ...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,...RegulatoryFull timeWorldwideRelocation package
$202.4k - $265.7k
...mark for patientsWe are looking for a RWE Strategy Lead Developed Brands, Immunology who is... ...lead the development and execution of global real-world evidence (RWE) strategies that... ...research, and data strategies that inform regulatory, market access, reimbursement, and...RegulatoryPermanent employmentContract workWork at officeLocal area$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, Nephrology in our Cambridge, MA... ...Global Project Team (GPT) and global brand strategy. This includes incorporating cross-functional... ...(e.g., Clinical, Commercial, Regulatory, PV, Health Economics and Outcomes, Market...RegulatoryMinimum wageWork at officeLocal areaRemote work$180k - $245k
...is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with... ...responsible for developing and executing regulatory strategies that support global product development and...Regulatory$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...according to the PDT Benign Hematology GM strategy in close collaboration with global key... ...Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout -...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work$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... ...role will interface extensively with regulatory, clinical, commercial, and external...RegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwide$206.25k - $297.92k
Job title: Real World Evidence Strategy LeadLocation: Morristown, NJ,... ...World Evidence (RWE) Strategy Lead, you will establish and execute RWE strategies across global Therapeutic Areas, translating... ...needs into evidence that drives regulatory, access and medical decisions....RegulatoryFull timeLocal area- ...though it's over 54,000 strong. As a Global Cloud Elite and Platinum member of the... ...understand how operational, financial, and regulatory reporting requirements translate into... ...and reporting architectures. You lead with strategy — designing frameworks that are sustainable...RegulatoryWork experience placementLive inWork at officeLocal area
$169.4k - $266.2k
...that support broader medical strategies and evidence-generation efforts. You will be part of a global, collaborative environment that... ...professional engagement objectives. Lead scientific content creation... ...by partnering with Legal and Regulatory colleagues to support accurate...RegulatoryMinimum wageFull timeLocal area- 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
$212k - $333.19k
...diligence, and supporting disease area strategy and early asset commercial planning.... ..., translating scientific, clinical, regulatory, and competitive insights into... ...judgment, and a demonstrated ability to lead in a highly matrixed global environment. You will report to the...RegulatoryMinimum wageLocal areaRemote work- Moderna is seeking an Associate Director for Global Regulatory Advertising and Promotion to ensure... ...and Commercial teams to guide advertising strategies while staying current with FDA requirements and APBL guidance. You will lead PMRT/MRC discussions, support FDA interactions...Regulatory
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