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
- ...Incorporated seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You will partner with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while...SuggestedRemote work
- 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
$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...development of robust and accurate submissions.Develops constructive relationships... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$154.4k - $242.55k
...Defines, develops and leads global strategies to maximize global regulatory success towards... ...Accountabilities:The Associate Director will be responsible for... ...for all US FDA submissions and approvals of project... ...currently classified as “hybrid” in accordance with Takeda...SuggestedMinimum wageTemporary workLocal areaRemote work$238k - $374k
...my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...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 wageTemporary workLocal areaRemote work$238k - $374k
...therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...global regulatory strategy and major submissions for an assigned portfolio of medical... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Global Submission Management (GSM) is responsible for the... ...and execution of a portfolio of global regulatory submissions across development and... ...k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility...Full timeSummer workRemote workFlexible hours2 days per week- ...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...
- ...Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners... .../CCDS labeling, manage SPL submissions, and drive lifecycle labeling... .... This role supports hybrid in-office engagement amid relocation...Work at officeRelocation
- ...internal stakeholders. This role is hybrid in either Cambridge, MA or... ...PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional... ...Operations and Supply Chain to ensure submission-ready labeling components comply...Local area
- ...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...
- 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...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading... .... Work Arrangement & Location Hybrid - This position follows a hybrid work... ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III development...Local areaFlexible hours2 days per week$130k - $155k
Compliance Manager, Global Private Equity | Boston (hybrid) Join a global investment firm with a long-standing reputation for excellence across private... ...exposure across a wide range of global products and regulatory frameworks, including private credit, evergreen funds,...Full time- 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...
- Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!) Overview A growing oncology biotech... ...in leading the company’s first NDA submission and partnering closely with executive...Relocation3 days per week
$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...$177k - $278.08k
Job Description Director, Global Regulatory Lead Oncology - responsible for setting global regulatory strategy and leading major submissions for high‑impact oncology programs. About the role... ...Information This position is classified as “hybrid” following Takeda’s Hybrid and...Temporary workLocal areaRemote 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... ...early development through commercializationDrive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgencyLead health...Permanent employmentFull timeWork at officeWork from home- ...GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative... ...regulatory leadership. The position allows for hybrid work arrangements, reflective of Alnylam's commitment...
- 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
- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses... ...functional teams to ensure timely and quality submissions to the FDA and other agencies. Ideal... ...requirements. Opportunities for hybrid work are available. #J-18808-Ljbffr...
$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- ...Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs... ...Lead, guiding IND/CTA/NDA/MAA submissions and lifecycle management across... ...and cross-functional leadership. Hybrid work schedule with on-site expectations...
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...
- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple... ...programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected,...
- ...Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development... ...advising teams, and ensuring compliance of submissions. Vertex offers a hybrid work model and a comprehensive benefits...
- ...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...
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...regulatory authorities as needed. Prepare regulatory submissions for promotional materials, including 2253 filings and...Permanent employmentWork at office
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