Director, Global Regulatory Submissions (Hybrid)
Vertex Pharmaceuticals
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 & Promotion. You will supervise submission management staff and vendor partners, drive continuous improvement, and leverage modern tooling like MS Project, Smartsheet, and Veeva RIM in a hybrid work environment. #J-18808-Ljbffr Vertex Pharmaceuticals
- ...(US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their... ...involves leading regulatory submissions and mentoring team members on... ...bonuses, equity awards, and a hybrid work model. #J-18808-Ljbffr...Suggested
- ...Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Senior Director to lead the development of... ...and involves overseeing regulatory submissions and communications. The successful... ...matrix environment. Vertex offers a hybrid work arrangement and competitive benefits...Suggested
$154.4k - $242.55k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...the development of robust and accurate submissions. Develops constructive relationships... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$238k - $374k
...knowledge. Job Description Executive Director, Global Regulatory Affairs CMC Early Development... ...global CMC regulatory strategies and submissions for small molecule and biologic products... ...position is currently classified as “hybrid” in accordance with Takeda’s Hybrid...SuggestedMinimum wageFull timeTemporary workLocal areaRemote work$238k - $374k
...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...global regulatory strategy and major submissions for an assigned portfolio of medical... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...SuggestedMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$139k - $172k
Akebia Therapeutics is seeking a Manager for Regulatory Affairs CMC based in Cambridge, MA, transitioning to Waltham, MA. This role involves implementing global CMC strategies and ensuring compliance for submissions to FDA and EMA. Candidates should have at least 5 years...- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy... ...with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a hybrid work model and a competitive salary ranging from...$170k - $190k
...Partners (U.K.) Limited in Boston is seeking a Director in the Tax Compliance function. This role... ..., including income tax provisions and global initiatives such as OECD Pillar Two. The... ...fund knowledge. The position offers a hybrid working arrangement with an attractive compensation...Remote job$177k - $278.08k
Initial Therapeutics, Inc. is seeking a Director Global Regulatory Affairs in Boston. The successful candidate will develop global regulatory strategies... ...to navigate regulatory landscapes. The role offers a hybrid work model and a competitive salary range of $177,000 to $2...$177k - $278.08k
...therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible... ...solutions. Accountable for all US FDA submissions and approvals of project(s) of... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle programs, including Pulmonary or Cell & Gene Therapy areas. You will partner with Global...
- Trade Compliance Recruiting Solutions is seeking a Global Trade Compliance Coordinator based near Boston, MA. This hybrid position involves managing daily import and export transactions while ensuring compliance with regulations such as CBP, EAR, and OFAC. The ideal candidate...
- Trade Compliance Recruiting Solutions is looking for a Global Trade Compliance Coordinator based in Boston, MA. This hybrid role involves managing import and export transactions, ensuring adherence to compliance regulations including CBP, EAR, and OFAC. The ideal candidate...Remote jobWork at office
$190.4k - $285.6k
## Director, Global Submission ManagementApplylocations: Boston, MAtime type: Full timeposted on: Posted... ...execution of a portfolio of global regulatory submissions across development and lifecycle... ...so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex...Summer workRemote workFlexible hours2 days per week$208.2k - $327.14k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...manner. Accountable for US FDA submissions and approvals of project(s) of responsibility... ...to people around the world. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits...Minimum wageFull timeTemporary workLocal areaWorldwide$174.5k - $274.23k
...Defines, develops and leads global strategies to maximize global regulatory success towards... .... Accountabilities: The Director will be responsible for... ...Accountable for all US FDA submissions and approvals of project... ...currently classified as “hybrid” in accordance with Takeda...Minimum wageFull timeTemporary workLocal areaRemote work- 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...
- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization... ...is currently classified as "remote" following Takeda’s Hybrid and Remote Work policy. Locations: CHE - Glattpark (...Full timeRemote workWorldwide
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...development through commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency Lead...Permanent employmentWork at officeWork from home- ...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...regulatory expectations. Lead the preparation, submission, and maintenance of regulatory applications,...
$177k - $278.08k
...changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the... ...through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/...Full timeTemporary workLocal areaWorldwide- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling... ...and alignment with business objectives. Takeda offers a hybrid work environment and a range of competitive benefits. #J-...
- ...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...
$270k - $330k
...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s)... ...planned meetings, regulatory boards).Lead the preparation of submissions incl PIP, scientific advice, orphan drug designation...Temporary workLocal areaWorldwideFlexible hours- Job Description Director Global Regulatory Affairs, Neuroscience responsible for developing innovative global regulatory strategies and providing... ...in cross‑functional initiatives, and manage U.S. FDA submissions and approvals. The Director also leads and manages direct...Local area
- **Job Description**The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence... ...with GRA and corporate goals. This is a Boston based, hybrid position requiring 3 days/week onsite.**Key Duties &...Summer workRemote workFlexible hours2 days per week3 days per week
- ...biopharmaceutical company is seeking a Director of Global Regulatory Strategy to lead strategies and... ...requirements. You will oversee FDA submissions, manage Global Regulatory Teams, and... ...role offers a competitive salary and hybrid work options. #J-18808-Ljbffr Takeda
$178.5k - $257.83k
Director, US Regulatory Affairs - Advertising & Promotion (Hybrid) Location: Cambridge, MA; Morristown, NJ About the Job: Shape the future of medicine by ensuring all... ...relationships with the FDA. Provide input to the global team on labeling strategies for marketed drugs....- 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...
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