Global Regulatory Submissions Director
Vertex Pharmaceuticals
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 Regulatory Strategy, CMC, Labeling, Publishing, and Advertising & Promotion to ensure timely, compliant submissions and data integrity. This role requires 7+ years in regulatory submission management, strong project management #J-18808-Ljbffr Vertex Pharmaceuticals
- ...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...Suggested
- 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...Suggested
$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...Suggested$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products.... ...10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a hybrid...Suggested- 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...Suggested
- Vertex Pharmaceuticals Inc (US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their portfolio. The role involves leading regulatory submissions and mentoring team members on regulatory frameworks...
- Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston, MA. This role involves leading global regulatory strategies for oncology programs, overseeing major submissions, and guiding cross-functional teams to deliver breakthrough treatments. The...Worldwide
- Takeda in Boston, MA seeks an Associate Director, Global Regulatory Lead Oncology to define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients globally. The...
$245k - $300k
Merida 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....- JobRx, Inc. is looking for a Director of Global Regulatory Affairs specializing in Neuroscience. This role involves developing innovative global... ...negotiation skills are essential, as you will manage FDA submissions and collaborate with global teams to navigate the regulatory...
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...executing regulatory strategies to support global product development, particularly in immunology... ...and the ability to manage regulatory submissions and work with health authorities such...
$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience in the... ...pharmaceutical industry, with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have proven...- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience in... .... This position includes responsibilities for FDA submissions and cross-functional collaboration to ensure project compliance...
- IPSEN is seeking a Senior Director, Global Regulatory Affairs, Oncology to provide regulatory strategic leadership and implement activities across... ...strategy development, management of regulatory submissions, and fostering strong relationships with key stakeholders...
- 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....
- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy... ...projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory requirements. The...
$190.4k - $285.6k
## Director, Global Submission ManagementApplylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29520**Job... ...oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This...Summer workRemote workFlexible hours2 days per week$154.4k - $242.55k
...therapies to patients worldwide. 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...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$238k - $374k
...life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic... ..., overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of...Full timeTemporary workLocal areaWorldwide- ...AstraZeneca is seeking a Senior Regulatory Affairs Director in Boston, MA to lead global regulatory strategy for oncology programs. The role involves overseeing a Global Regulatory Strategy Team and ensuring competitive labeling. The ideal candidate has an advanced degree...Work at officeRemote work
$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$238k - $374k
...‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product,... ...experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug‑device...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- ...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,...
- A leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic regulatory leadership for oncology programs, ensuring compliance, and overseeing global regulatory strategies. The ideal...
$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- Vertex Pharmaceuticals Inc. is seeking a Regulatory Labeling Director to lead strategic development of global labeling for marketed products, including CCDS and regional labeling (PI, PIL, IFU) across US, EU, GB, and CA. The role interfaces with FDA, EMA, and Health Canada...
$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- ...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...
- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...
- 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
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