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
- ...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....Suggested
- ...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
- 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...Suggested
- 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...Suggested
$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...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- 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...
- 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
- 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...
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead regulatory plans for select programs... ...requires strategic leadership within Global Regulatory Science to address... ...negotiate with health authorities, guide submissions, and monitor evolving regulatory landscapes...
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...Remote jobPermanent employmentContract work
- 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...
$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- ...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...
- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...
$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
...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$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...
- ...Pharmaceuticals Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule... ...portfolio. You will guide content for submissions, engage Health Authorities, and drive...
- ...Manufacturing Controls Manager to lead regulatory CMC activities for both investigational... ...involves reviewing CMC sections, developing global strategies, and coordinating with cross-... ...teams to ensure compliance and timely submissions. You will act as the primary CMC contact...
$167k - $300.7k
The Role Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within... ...will be a strategic leader within Global Regulatory Science, responsible for developing... ...development content and management of submissions to Health Agencies. Sets strategic...Permanent employmentWork at officeWork from home$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development... ...and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements...Local area
- ...Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the... ...messenger RNA technology in the US and other global markets. Responsibilities Serve as... ...global strategy, including for IND submissions. Lead the strategy for US FDA...
- ...Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic... ..., to ensure alignment between US and global strategies. Exceptional communication... ...FDA interactions and regulatory submissions. The role offers robust healthcare benefits...
$168k - $252k
Job DescriptionGeneral Summary:The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs... ...the process for preparation, submission, and approval of regulatory applicationsProvides...Full timeSummer workRemote workFlexible hours2 days per week$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and...Local areaFlexible hours2 days per week
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