Senior Director, Global Regulatory Submissions & Operations
Meet Life Sciences
A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate has 6+ years of regulatory affairs experience, strong skills in eCTD publishing, and works well in cross-functional settings. This position offers competitive compensation and the opportunity to contribute to innovative oncology therapies. #J-18808-Ljbffr Meet Life Sciences
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads,... ...determining the impact on business operations and compliance programs Implement... ...preparing and managing regulatory submissions with minimal guidance Skilled in analyzing...OperationsSeniorFull timeLocal area
- Takeda in Boston, MA, seeks an experienced Regulatory CMC professional to lead submission planning and execution for clinical and post‑marketing programs. You will work with global teams to align regulatory strategy with product development goals. The role emphasizes regulatory...Senior
$146.96k - $210.1k
...Provides critical support in developing global regulatory strategy, planning and execution of... ...investigational and marketed prescription drug submissions and manages lifecycle activities for... ...labeling, medical writing, regulatory operations, etc.) to develop global regulatory...OperationsSeniorTemporary workWork at officeLocal areaFlexible hours$208.2k - $327.14k
Overview Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) - role at BioSpace, as described in the job posting. The Plasma-Derived... ...business by overseeing all PDT regulatory submissions globally to ensure proper resourcing,...OperationsSeniorFull timeRemote workFlexible hours- ...Senior Manager – Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global Clinical Programs I’m currently supporting an... ...increasing number of regulatory submissions and interactions with... ...Reporting into the Director of Regulatory Affairs...OperationsSenior
- 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...Operations
- ...strategic and experienced Senior Director of Regulatory Affairs to lead and execute... ...—from IND through BLA submission and approval. You will manage... ...Develop and execute integrated global regulatory strategies to... ..., Biostatistics, Clinical Operations, Medical Affairs, and...OperationsSeniorWork at officeLocal area3 days per week
- Inventiva Pharma is seeking a Senior Director, Compliance to lead and scale global compliance and data privacy programs... ...in ensuring adherence to legal, regulatory, and ethical obligations... ...supporting late-stage clinical operations and future commercialization efforts...OperationsSenior
$196.7k - $353.4k
...to lead development and execution of global regulatory strategy for programs in its oncology... ...convention, delivering with excellence, and operating as an enterprise leader. The... ...through commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence...SeniorPermanent employment- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The... ...the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a BS/BA...Senior
$137k - $165k
A global biotechnology firm in Boston is looking for a Senior Manager, Global Trade Compliance. This strategic leadership role is responsible for overseeing the company's export control program, aligning operations with international regulations, and managing compliance...OperationsSenior- Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!) Overview... ...a critical role in leading the company’s first NDA submission and partnering closely with executive leadership to...SeniorRelocation3 days per week
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging... ..., including a strong background in regulatory submissions. The position is based in Boston, MA, and...Senior$177k - $278.08k
...worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where... ...content. Interface with Senior Management Cross‑Functional... ...Labeling Documents Authoring, Submission, and Labeling Negotiations... ...Liaises with US Labeling Operations, EU Labeling Operations,...OperationsFull timeTemporary workLocal areaWorldwide$212k - $333.19k
...patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be... ...stages. Provide strategic, operational and tactical regulatory insight on... ...timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility...SeniorMinimum wageTemporary workLocal areaWorldwide$212k - $333.19k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... .... Accountabilities: The Senior Director will be responsible for complex... ...solutions. Accountable for all US FDA submissions and approvals of project(s) of...SeniorMinimum wageTemporary workLocal area- Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs, aligning with regulatory strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising...
$245k - $300k
...an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory strategies across our... ...Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance... ...guidance on regulatory pathways, submission strategies, expedited programs...OperationsSeniorLocal area- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech... ...CMC Manager to support the global development and... ...as they prepare for a BLA submission. Key Responsibilities Lead... ..., Quality, and Technical Operations to ensure compliance with...OperationsSenior
- JOB TITLE Executive Director, Regulatory Operations and Submission Management DEPARTMENT Regulatory Affairs REPORTS TO Head of Regulatory Affairs SUPERVISES... ...will provide strategic and operational leadership for global regulatory operations and systems, submission...Operations
$270k - $285k
.... Position Description The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for... ...regulatory partner to Technical Operations, Quality, and Supply Chain,... ...leading post-approval submissions, including supplements, variations...OperationsSeniorFull timeWork at office3 days per week$137k - $165k
...Overview The Senior Manager, Global Trade Compliance – Export Compliance is... ...In partnership with the Sr. Director of Global Trade Compliance,... ...programs, and ensure adherence to regulatory requirements across all... ...in which the company operates. Primary Responsibilities Regulatory...OperationsSeniorFull timeTemporary workPart timeWork at officeLocal area$238k - $294k
...Description The Sr. Director, Regulatory Affairs Advertising,... ...responsible for leading global product labeling and... ...provides strategic and operational leadership to ensure... ...prior to submission or implementation. Advertising... ...partner effectively with senior leaders. Strong...OperationsSeniorFull timeWork at officeFlexible hours3 days per week- Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview Senior regulatory role within global R&D (Chemistry, Manufacturing & Controls - CMC) Responsible for executing regulatory strategy across clinical...Senior
- Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of regulatory strategies for complex projects... ...is based in Boston and involves overseeing regulatory submissions and communications. The successful candidate will have...Senior
- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience in regulatory... .... This position includes responsibilities for FDA submissions and cross-functional collaboration to ensure project...Senior
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and... ...will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
- 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...
- Discover International is seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution.... ...for complex pharmaceutical products and guiding major submissions. The ideal candidate will have over 10 years of...
$137k - $215.27k
...patients worldwide. About the role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...that enables the development of robust and accurate submissions. Develops constructive relationships with and proactively communicates...SeniorMinimum wageFull timeTemporary workLocal areaWorldwide
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