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
- Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs. The role requires 8+ years in regulatory affairs...Suggested
- Scorpion Therapeutics is seeking a Director of Global Submission Management to provide strategic oversight and execution of a portfolio of regulatory submissions across development and lifecycle programs. You will lead submission planning, timelines, and cross-functional...Suggested
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... ...influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...Suggested
- ...Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory... ...controls deliverables. You will support global filing strategies, coordinate with... ...Quality, and ensure timely, compliant submissions across development, commercialization,...Suggested
$145k - $185k
A biotechnology company is seeking a highly motivated Senior Manager for Regulatory Affairs Operations. This role involves overseeing regulatory submissions and managing compliance with global standards. Candidates should have a solid understanding of the pharmaceutical...SuggestedRemote job- 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...
- ...Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface with...
- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. You will serve as the... ...Leader and US Regulatory Lead, guiding IND/CTA/NDA/MAA submissions and lifecycle management across regions. The role...
- 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...
- 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...
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early... ..., CMC, Non‑Clinical Sciences, and Bioanalytics to drive IND/CTA and NDA/BLA submissions, #J-18808-Ljbffr BioSpace
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios... ...with Regulatory Science and Project teams to manage submissions, monitor regulatory intelligence, and lead process...
$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This role will manage submissions for development...Full timeSummer workRemote workFlexible hours2 days per week- ...Medicines in the United States is seeking an Executive Director, Regulatory Affairs to serve as Global Regulatory Lead for assigned programs and report to... ...You will drive global regulatory strategy, oversee submissions (IND/CTA/NDA/MAA) and ensure compliance across...For contractors
- Scorpion Therapeutics seeks an Associate Director, Global Submission Management to orchestrate global regulatory submissions across development and lifecycle programs. This role focuses on Pulmonary or Cell & Gene Therapy areas and partners with Strategy, CMC, Labeling,...
$154.4k - $242.55k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... ....Accountabilities:The Associate Director will be responsible for complex or... ....Accountable for all US FDA submissions and approvals of project(s) of responsibility...Minimum wageTemporary workLocal areaRemote work$154.4k - $242.55k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...that enables the development of robust and accurate submissions.Develops constructive relationships with and proactively communicates...Minimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a... ...innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2...Minimum wageTemporary workLocal areaRemote work$238k - $374k
...life-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-...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$180k - $245k
...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, including...$196.7k - $353.4k
...Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs... ...on to articulate clear and compelling global regulatory strategies, highlighting risks... ...and accountability for regulatory submissions and related supplements and amendments...Permanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...early development through commercializationDrive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgencyLead health...Permanent employmentFull timeWork at officeWork from home$190.4k - $285.6k
General Summary: The Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs, including planning, submission, and closeout, to enable and advance global...$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage indications,...Full timeTemporary workWork experience placementWork at officeWorldwide- ...Reference26-00886 Job Description: 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...
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy...
$190k - $210k
...treatment paradigm and access a $15 billion global market opportunity. Our follow-on... ...s beyond . About the Role Associate Director, Global Regulatory Affairs, Compliance As the Global... ...of high-quality regulatory submissions—including INDs, NDAs, health authority...Work at officeFlexible hours2 days per week- Associate Director, Global Regulatory Affairs - Marketed Products Boston, Massachusetts | Hybrid Working Are you an experienced Regulatory Affairs... ...execution of regulatory plans Managing regulatory submissions, approvals, lifecycle management activities, and post‑marketing...Worldwide
$155k - $190k
...experiences to join our team. What You’ll Do The Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory... ...phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions...Full timeLocal areaFlexible hours3 days per week- Moderna, in the United States, seeks an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles... ...strategies, and guide product teams toward compliant submissions. You will lead interactions with health authorities,...
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