Senior Global Regulatory Submissions Lead
Mass Digital Health
Sanofi in Morristown, NJ and Cambridge, MA seeks a Global Submission Lead to manage worldwide regulatory submissions. You will coordinate dossier formats, standards, and lifecycle management across programs, working with GRA, external partners, and cross-functional teams to ensure timely, compliant submissions. The role requires 5+ years in regulatory operations, strong ICH/eCTD knowledge, and expertise in submission planning and vendor oversight. Domestic/international travel may be required. #J-18808-Ljbffr Mass Digital Health
$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...professional and timely manner.Accountable for US FDA submissions and approvals of project(s) of responsibility. May...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and... ...through large-scale Phase III/submission projects and global launch projects...SeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring... ...qualifications: Expert in preparing and managing regulatory submissions with minimal guidance Skilled in analyzing complex...SeniorRegulatoryFull timeLocal area
- Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs. This hands-on role drives document readiness, eCTD publishing, cross-functional coordination...Regulatory
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
$122.25k - $176.58k
Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global Submission Lead within our R&D team , you... ...responsible for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission activities...RegulatoryWorldwideFlexible hours- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our team in Cambridge, Massachusetts. This role... ...6 years of medical writing experience, familiarity with regulatory submissions, and excellent project management skills. A comprehensive benefits...SeniorRegulatoryContract work
- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep... ...and experience coordinating multi‑team studies and regulatory submissions. #J-18808-Ljbffr RegeneronSeniorRegulatory
$100k - $143k
Relaytherapeutics in Cambridge, Massachusetts is looking for a motivated regulatory professional to join their regulatory team. In this role, you... ...pipeline, contributing to IND, CTA, NDA, and MAA submissions. Ideal candidates will have a B.S. or M.S., 2+ years of relevant...Regulatory- 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
$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$243.59k - $365.38k
Role Summary:Reporting to the Global Medical Head of CardioRenal, the Senior GMAL is a highly experienced Medical Affairs... .... This individual develops and leads bold medical strategies within the... ...of healthcare system pathways, regulatory landscapes, market access, and competitive...SeniorRegulatoryFull timeTemporary workWorldwide- ...scientific and operational stability leader to design and manage stability studies, interpret data, and support shelf-life and regulatory submissions for development, clinical, or commercial programs. This onsite role is based at Moderna’s Technology Center campus in...SeniorRegulatory
$178.1k - $244.86k
...PURPOSELead development and advancement of Global Patient Access (GPA) strategies across... ...ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle... ...compliant access globallyACCOUNTABILITIES Lead end-to-end strategy development and execution...SeniorRegulatoryMinimum wageTemporary workLocal areaNight shift- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology company... ...planning. This role is pivotal in leading regulatory interactions with... ...overseeing regulatory documentation and submissions for late-stage development,...SeniorRegulatory
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The... ...with cross-functional teams. This mid-senior position focuses on ensuring timely, compliant...SeniorRegulatoryFull time
$154.4k - $242.55k
...empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU... ..., MA reporting to the Senior Director, Head Inflammation... ...and documents submitted to Regulatory Agencies.• Establish and maintain... ...publications, regulatory submissions, and/or national or international...RegulatoryMinimum wageTemporary workLocal area- 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... ...lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives...Regulatory
$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout -... ...with vendor(s) to ensure timely submission and approvalActively track, enter and...RegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote work- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance for promotional materials across... ..., with global regulatory knowledge and experience in submissions and health authority interactions. A 70/30 in-person work model...Regulatory
- ...and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is... ...Area and supports manager and/or Global Regulatory Lead (GRL) in the... ...preparation and review of regulatory submissions consistent within US and Canada...SeniorRegulatoryLocal area
$137k - $215.27k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...as follows: With some supervision, leads the execution of regulatory CMC investigational... ...the development of robust and accurate submissions.Develops constructive relationships...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$212k - $333.19k
...therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...prospective and proactive implementation. Globally influence and serve as a key... ...aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs,...SeniorRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... ...will guide product teams and prepare CMC/Quality regulatory submissions with stakeholders to drive timely approvals. The role...Regulatory
- Scholarrock in Cambridge, MA is seeking a Director or Senior Director of Regulatory Strategy to lead the global regulatory strategy for clinical and pipeline... ...The successful candidate will oversee regulatory submissions, manage relationships with regulatory authorities,...Regulatory
- ...seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... ...will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...Regulatory
- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization... ...compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s degree, extensive...SeniorRegulatoryRemote work
- Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative... ...on Human Factors, regulatory submissions, and cross-functional... ...regulatory strategies, interfacing with global health authorities, and ensuring high...Regulatory
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...Regulatory
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