Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Submissions Director in Boston, MA vacancy
  •  ...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

    Noema Pharma AG

    Boston, MA
    4 days ago
  • 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

    Page Mechanical Group, Inc.

    Boston, MA
    22 hours ago
  • $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

    Scorpion Therapeutics

    Cambridge, MA
    2 days ago
  • $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

    JobRx, Inc.

    Boston, MA
    22 hours ago
  • 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

    Boston, MA
    12 hours ago
  • 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... 

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    22 hours ago
  • 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

    Initial Therapeutics, Inc.

    Boston, MA
    2 days ago
  • 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... 

    Takeda

    Boston, MA
    1 day ago
  • $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.... 

    Merida Biosciences

    Cambridge, MA
    1 day ago
  • 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... 

    JobRx, Inc.

    Boston, MA
    3 days ago
  • 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... 

    Monte Rosa Therapeutics, Inc

    Boston, MA
    2 days ago
  • $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... 

    Takeda

    Boston, MA
    4 days ago
  • 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... 

    Initial Therapeutics, Inc.

    Boston, MA
    2 days ago
  • 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... 

    IPSEN

    Cambridge, MA
    4 days ago
  • 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

    Boston, MA
    2 days ago
  • 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... 

    JobRx, Inc.

    Boston, MA
    1 day ago
  • $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 work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    13 hours ago
  • $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 wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    5 days ago
  • $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 time
    Temporary work
    Local area
    Worldwide

    JobRx, Inc.

    Boston, MA
    2 days ago
  •  ...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 office
    Remote work

    Dormont Manufacturing Company

    Boston, MA
    22 hours ago
  • $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 employment
    Work at office
    Work from home

    Moderna

    Cambridge, MA
    1 day ago
  • $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 wage
    Full time
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  •  ...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,... 

    Monte Rosa Therapeutics, Inc

    Boston, MA
    1 day ago
  • 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... 

    Page Mechanical Group, Inc.

    Boston, MA
    3 days ago
  • $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 time
    Temporary work
    Local area
    Worldwide

    Takeda

    Boston, MA
    4 days ago
  • 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... 

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    1 day ago
  • $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 work
    Local area
    Worldwide
    Flexible hours

    IPSEN

    Cambridge, MA
    2 days ago
  •  ...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... 

    Initial Therapeutics, Inc.

    Boston, MA
    3 days ago
  • 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... 

    Allergan

    Cambridge, MA
    3 days ago
  • 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

    JobRx, Inc.

    Boston, MA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Submissions Director. Be the first to apply!