Global Submissions & Regulatory Operations Lead
Mass Digital Health
Mass Digital Health is seeking a Global Submission Lead in Cambridge, MA, or Morristown, NJ. This role focuses on planning, coordination, and execution of regulatory submission activities within the R&D team at Sanofi. The ideal candidate will have over 5 years of experience, a bachelor's degree in a related field, and a deep understanding of global regulatory guidelines. The position involves collaboration with cross-functional teams and external partners to ensure timely delivery of high-quality submissions, supporting Sanofi's mission of innovative medicine delivery. #J-18808-Ljbffr
- ...Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...Regulatory
- ...AVEO Oncology is seeking an Executive Director for Regulatory Operations. This role involves providing strategic leadership for global regulatory operations, ensuring compliance and submission quality across the product lifecycle. The successful candidate will establish...Regulatory
- ...AVEO Pharmaceuticals is seeking an Executive Director of Regulatory Operations to lead global submission management and ensure compliance and quality across submissions. The role requires extensive experience in regulatory operations and managing high-performance teams...Regulatory
- ...A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing... ...prepare regulatory submissions, interact with health... ...for supporting ongoing global clinical studies. #J-1...Regulatory
- ...Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston, MA. This... ...with proficiency in eCTD submissions and vendor oversight. The candidate... ..., maintain compliance with global standards, and prepare... ...position offers an opportunity to lead cross-functional teams and...Regulatory
- ...action today. Job Mission The GSOC Lead Analyst serves as a senior operational resource responsible for advanced... ...personnel, facilities, assets, and global operations. This role provides... ...documentation for compliance and regulatory alignment. Support project‑based work...RegulatoryTemporary workPart timeWork at officeAll shiftsFlexible hoursShift workNight shift3 days per week
- ...A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs...Regulatory
$246.33k - $304.29k
...Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...RegulatoryFlexible hours$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$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory Operations Global Submission Managementlocations... ...our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication,...RegulatoryMinimum wageFull timeLocal areaRemote workFlexible hours$177k - $278.08k
...JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products... ...requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a...Regulatory- ...Are you ready to lead global cell therapy programs that accelerate... ...As a Senior Global Clinical Operations Program Director, you will guide... ...and turning bold ideas into regulatory-ready results? This is your... ...components of regulatory submissions, support regulatory interactions...RegulatoryContract workWork experience placement
- ...Global Project Head, Rare job at Sanofi (US). Cambridge... ...as interaction with regulatory/health authorities (HA... ...program strategy and leads the international... ...and objectives Ensures operational plans are integrated across... ...Ensures timely submission and dissemination of clinical...Regulatory
- ...Job Title Global Project Head, Gastrointestinal Oncology Leader... ...asset portfolio optimization. Lead late‑stage asset development... ...advisory boards, and worldwide regulatory authorities. Contribute to the... .... Experience in successful submissions for marketing authorization....RegulatoryWorldwide
- ...Executive Director, Regulatory Operations and Submission Management The Executive Director, Regulatory Operations... ...and operational leadership for global regulatory operations and systems, submission... ...role is accountable to build and lead a high-performing Regulatory...Regulatory
$122.25k - $176.58k
...Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...continuous evaluation to drive operational effectiveness for regulatory submissions...RegulatoryWorldwideFlexible hours$238k - $374k
...JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry... ...experience, with significant expertise in regulatory submissions for medical devices and combination products. You will oversee...Regulatory$75k - $108.33k
Job Title Global Submission Associate Location Morristown, NJ About the... ...Submission Managers and Submission Leads to support the publishing... ...submission documentation to regulatory health authorities according... ...organization. Ability to operate with agility in a dynamic...RegulatoryLocal area$270k - $330k
...Ipsen Biopharmaceuticals Inc. is looking for a Senior Director of Global Regulatory Affairs specializing in Oncology. This critical role demands extensive regulatory leadership to manage programs, ensuring compliance and strategic alignment with global development objectives...Regulatory- ...Job title: Global Regulatory Strategist Location: Morristown, NJ/ Cambridge, MA About the... ...for the oncology therapeutic area, leading regulatory efforts in the development... ...within remit, as needed Regulatory Submissions & Operations Leads submission teams or regulatory...RegulatoryLocal area
$153.6k - $241.34k
...A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston...Regulatory- ...seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must...Regulatory
$245k - $300k
...Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics. Key...Regulatory- ...Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This senior role requires a candidate with strategic leadership skills and over 10 years of regulatory experience in the pharmaceutical...RegulatoryLocal area
- ...Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy... ..., with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory requirements. The...Regulatory
- ...Therapeutics in Cambridge, Massachusetts is looking for a Regulatory CMC Product Lead to independently develop and execute regulatory... ...CMC requirements. This role involves leading submissions, ensuring compliance with global regulations, and building relationships with...Regulatory
- ...Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic... ...regulatory strategies to support global product development, particularly in immunology... ..., and the ability to manage regulatory submissions and work with health authorities such as...Regulatory
- ...Takeda in Boston is seeking an experienced professional to lead Regulatory CMC strategies and manage regulatory submissions. The candidate should have over 6 years of experience in pharmaceutical regulatory affairs and a strong foundation in CMC regulations. This role...Regulatory
- ...IPSEN is seeking a Senior Director, Global Regulatory Affairs, Oncology to provide regulatory strategic leadership and implement activities... ...regulatory strategy development, management of regulatory submissions, and fostering strong relationships with key stakeholders. #J...Regulatory
- ...JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience.... ...global regulatory strategies and leading Global Regulatory Teams. The ideal candidate... ...are essential, as you will manage FDA submissions and collaborate with global teams to...Regulatory
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