Global Regulatory Submissions Lead (Cambridge)
Merida Biosciences
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 with regulatory affairs, and strategic execution to ensure timely, compliant submissions while enabling efficient regulatory operations.
#J-18808-Ljbffr- ...Merida Biosciences is seeking an Associate Director of Regulatory Affairs Operations. This hands-on leader will drive regulatory submission planning, execution, and lifecycle management across development programs, partnering with Regulatory Affairs leadership and cross...RegulatoryFull time
- Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global Submission Lead within our R&D team , you will be responsible... ...for the planning, coordination, and tracking of regulatory Priority portfolio and Integration submission...RegulatoryWorldwideFlexible hours
- ...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...RegulatoryFull time
$193k - $210k
...A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers a...RegulatoryFull time$174.5k - $274.23k
...Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives... ...for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work- ...is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development... ...on Human Factors, regulatory submissions, and cross-functional collaboration.... ...regulatory strategies, interfacing with global health authorities, and ensuring high...Regulatory
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
$154.4k - $242.55k
...About the Role The Global Brand Lead, ITP (Associate Director) is responsible for driving global... ...closely with Medical, Legal, and Regulatory teams to ensure materials are compliant... ...5%. Compensation & Benefits Location: Cambridge, MA. U.S. base salary range: $154,400....RegulatoryFull timeTemporary workLocal area$245.45k - $381.11k
...Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global value... ...other evidence generation initiatives to support regulatory, HTA, and payer submissions, and demonstrate the differentiated value of our...RegulatoryTemporary workLocal areaFlexible hours- ...Therapeutics in Waltham, MA seeks an hands-on Associate Director, Regulatory Affairs CMC to lead global RegCMC strategy across small‑molecule programs from IND... ..., and Program teams, and ensure timely regulatory submissions to advance development and commercialization. The role...RegulatoryFull time
- ...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...Regulatory
- ...Moderna Therapeutics in Cambridge is seeking a Global Medical Director to lead medical affairs strategy across the oncology portfolio, from early development... ...responsibilities such as aligning development and regulatory functions, overseeing governance, and financial planning...RegulatoryFull time
- Objectives/Purpose The Global Medical Communications Lead, Dermatology is a key strategic partner of the Global Medical Affairs team, responsible... ...communications agency Familiarity with international regulatory and legal guidelines regarding medical communication...RegulatoryFull timeRemote work
$196k - $269.5k
## Director, Global Indication Lead, RheumatologyApplylocations: Boston, MA, USAtime type: Full timeposted on: Posted Yesterdayjob requisition... ...being highly preferred* Deep understanding of the legal, regulatory and commercial environment across major global markets (US,...RegulatoryTemporary work- ...AstraZeneca GmbH is seeking a Global Product Lead for Immunology Research and Development based in Cambridge, Massachusetts. This role focuses on driving strategy for early stage immunology programs, where you'll influence key stakeholders and lead cross-functional teams...Full time
$170.9k - $231.3k
## Associate Director, Regulatory Affairs, CMCUnited... ...developing and implementating global CMC regulatory... ...primarily located in our Cambridge, MA or Philadephia, PA... ...Key Responsibilities * Lead the development and... ...Experience with regulatory submissions and health authority...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours- ...company committed to establishing the leading, fully integrated platform for precision... ..., and strategic Vice President, Global RWE and HEOR Strategy to spearhead the... ..., clinical development plans, and regulatory submissions; lead development of clinical sections...RegulatoryFull time3 days per week1 day per week
$260k - $360k
Rhythm Pharmaceuticals Inc. is seeking a Vice President of Regulatory Affairs to lead its Global Regulatory Affairs organization from Boston, Massachusetts. This senior role involves managing diverse teams, executing regulatory strategies, and ensuring high-quality outcomes...RegulatoryFull time- ...Cloud909 Inc. is seeking a CEO to chart the vision, accelerate growth, and compete with global infrastructure platforms. You will lead a world-class executive team and collaborate with investors and customers to steer the company toward a dominant market position. As...Full timeWorldwide
- ...State Street is seeking an expert to lead its Global Legal Entity Governance team, shaping governance frameworks and lifecycle management... ..., Finance, and business units, overseeing data governance, regulatory compliance, and technology-enabled entity management solutions...RegulatoryFull timeWorldwide
- ...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....RegulatoryFull time
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...RegulatoryFull time
- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy... ...with cross-functional teams to ensure timely and quality submissions to the FDA and other agencies. Ideal candidates will have...Regulatory
- ...States seeks a Senior Director, Global Regulatory Strategy – Oncology to lead regulatory strategies for asset development... ..., and Commercial teams to shape submissions and ensure regulatory alignment... ...in U.S. locations such as Cambridge, MA, Waltham, MA, or Rockville, MD...Regulatory
$170.9k - $231.3k
...Overview The Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS programs... ...lead the regulatory strategy and facilitate submission of data packages to the US. The role is responsible...RegulatoryFull timeTemporary workLocal areaFlexible hours$169.68k - $254.52k
...Translational Imaging Lead The Director, Translation... ...imaging strategies; Direct the global oncology Radiomics approach,... ...collaborations; Ensure regulatory compliance of imaging... ...United States : Massachusetts : Cambridge Division: Pharmaceuticals...Regulatory$212k - $333.19k
...About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...prospective and proactive implementation. Globally influences and serves as a key... ...related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs...RegulatoryFull timeTemporary workLocal areaWorldwideNight shift$210.9k - $379.2k
...Role Overview The Global Medical Director at Moderna leads medical affairs strategy across the oncology portfolio, spanning from early development... ...bodies and cross‑functional forums, aligning development, regulatory, and commercial functions. Lead the Development...RegulatoryFull timeWorldwide- ...patient outcomes. We built a leading performance-driven network of... ...Iterative Health is headquartered in Cambridge, Massachusetts, and New York... ...across Iterative Health's global research network — overseeing... ...requirements, and applicable regulatory standards. Performs related...RegulatoryContract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
$251.61k - $377.42k
...About AstraZeneca AstraZeneca is a global, science‑led, patient‑focused biopharmaceutical... ...diseases. We are one of the world’s leading pharmaceutical companies. Immunology... ...progressive discharge of technical and regulatory risk, and ultimately a differentiated and...RegulatoryHourly payFull timeTemporary work
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