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

Global Regulatory Lead — Drive Global Approvals & Strategy

Sarepta Therapeutics

Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions with Health Authorities for global programs. The role partners with cross-functional teams, manages junior staff, and oversees budgets. Hybrid work on-site at Sarepta facilities in the United States is expected, with periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements, while #J-18808-Ljbffr Sarepta Therapeutics

Vacancy posted 5 hours ago
Similar jobs that could be interesting for youBased on the Global Regulatory Lead — Drive Global Approvals & Strategy in Cambridge, MA vacancy
  •  ...Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program,...  ...and managing health authority interactions to drive #J-18808-Ljbffr ClinLab Solutions Group
    Regulatory

    ClinLab Solutions Group

    Watertown, MA
    2 days ago
  • $230k - $250k

     ...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company...  ...could lead to our first potential approval and commercial launch in 2028....  ...required to advance our programs, the drive to succeed, and a collective capacity... 
    Regulatory
    Work at office
    Flexible hours
    2 days per week

    Olema Oncology

    Boston, MA
    17 hours ago
  • A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical...  ...compliance and securing regulatory approvals for new products. The...  ...all FDA submissions, driving strategic regulatory initiatives... 
    Regulatory

    Takeda

    Cambridge, MA
    1 day ago
  • Sanofi in the US seeks a Global Periodic Reporting Lead based in Cambridge, MA (also Morristown, NJ and Swiftwater, PA). You...  ...the portfolio. You will develop outsourcing strategies, ensure regulatory compliance, and drive Lean process improvements to boost efficiency... 
    Regulatory
    Worldwide

    Sanofi

    Cambridge, MA
    4 days ago
  • $212k - $333.19k

     ...shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA...  ...(s). The GPL defines the asset strategy and leads all development and LCM projects...  ...leadersCommitted to simultaneously driving regulatory approval as well as launch and global... 
    Regulatory
    Minimum wage
    Work at office
    Local area
    Remote work

    Takeda

    Cambridge, MA
    17 hours ago
  • $192.4k - $302.39k

     ....Job DescriptionThe Global Medical Affairs Lead, PDT Immunology is responsible...  ...year global medical strategy for the PDT...  ...Affairs, clinical, regulatory, safety, compliance,...  ...medical review and approval of Investigator Initiated...  ..., motivate, and drive results through influence... 
    Regulatory
    Minimum wage
    Local area
    Remote work

    Takeda

    Somerville, MA
    4 days ago
  • $154.4k - $242.55k

     ...Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived...  ...review by the Labeling Team and approval by the executive governance committees...  ...external multiple stakeholders to drive solutions and set prioritiesHigh ability... 
    Regulatory
    Minimum wage
    Local area

    Takeda

    Cambridge, MA
    17 hours ago
  • Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings... 
    Regulatory

    USA - 3316 Takeda Development Center Americas, Inc.

    Cambridge, MA
    4 days ago
  • Takeda is seeking an Associate Director, Global Regulatory Project Management and Strategic...  ...role partners with the Global Regulatory Lead to ensure robust global project plans, cross...  ...align operational plans with GTMs, and drive strategic execution with vendors and external... 
    Regulatory
    Remote job

    USA - 3316 Takeda Development Center Americas, Inc.

    Cambridge, MA
    4 days ago
  • $200k - $265k

     ...bold ambition to become the leading dermatology company in the...  ...impact.The OpportunityLeads the global regulatory strategy, submission planning, and...  ...for Nemolizumab across all approved and development-stage...  ...supporting nemolizumab and for driving successful regulatory... 
    Regulatory
    Full time
    Temporary work
    Work experience placement
    Work at office
    Worldwide

    Galderma

    Boston, MA
    4 days ago
  • Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority... 
    Regulatory
    Work at office
    3 days per week

    Repertoire Immune Medicines

    Watertown, MA
    1 day ago
  • $196.7k - $353.4k

     ...seeking a Sr. Director of Regulatory Strategy to support oncology...  ...in gaining market approval for messenger RNA therapeutics...  ...clear and compelling global regulatory strategies,...  ...direction and leads the development of content...  ...day, our people are the driving force behind our... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Somerville, MA
    2 days ago
  • $182k - $346k

     ...Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience), is responsible...  ...to secure and maintain market approval for product(s) in the...  ...to operating with integrity, driving innovation, transforming lives... 
    Regulatory
    Worldwide

    ABBVIE

    Cambridge, MA
    17 hours ago
  • $177k - $278.08k

     ...worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be...  ...functional collaboration and driving alignment of the labeling strategy...  ...with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management... 
    Regulatory
    Minimum wage
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    17 hours ago
  • $177k - $278.08k

     ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the...  ...Oncology you will set global regulatory strategy and lead major submissions for high-...  ...Accountable for all US FDA submissions and approvals of project(s) of responsibility.... 
    Regulatory
    Minimum wage
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    17 hours ago
  • $212k - $333.19k

     ...the R&D Procurement team, leading category strategy and a team of category managers...  ...performance management to drive continuous improvement,...  ...support business objectives, regulatory requirements, quality standards...  ...:As members of Global Procurement, you are expected... 
    Regulatory
    Minimum wage
    Contract work
    Local area

    Takeda

    Boston, MA
    4 days ago
  •  ...innovation? As the Senior Global Medical Affairs Leader...  ...investment decisions, lead pre-launch scientific...  ...functional collaboration and drive innovation. Are you...  ...and leads bold medical strategies for MASH within the...  ...healthcare system pathways, regulatory landscapes, market... 
    Regulatory
    Full time
    Worldwide
    Relocation package

    AstraZeneca

    Boston, MA
    4 days ago
  • $180k - $245k

     ...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our...  ...developing and executing regulatory strategies that support global product...  ...programs from early development through approval and lifecycle management.Ensure regulatory... 
    Regulatory

    Monte Rosa Therapeutics

    Boston, MA
    17 hours ago
  • $142.5k - $256.5k

    The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory...  ...global regulatory CMC strategies and collaborating with key...  ...authorities to facilitate review and approval of submissionsPerform...  ...matrix environment to drive meeting each program’s critical... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    1 day ago
  • $192.4k - $302.39k

     ...you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in...  ...the PDT Benign Hematology GM strategy in close collaboration with...  ...Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout...  ...in creating post-approval studies, medical strategies... 
    Regulatory
    Minimum wage
    Temporary work
    Work experience placement
    Work at office
    Local area
    Remote work

    Takeda

    Somerville, MA
    17 hours ago
  • $210.9k - $379.2k

     ...worldwide, contributing to global health initiatives....  ...seeking a Global Medical Lead to lead medical affairs strategy across our Oncology portfolio...  ...governance leadership, and driving scientific thought...  ...interface extensively with regulatory, clinical, commercial, and... 
    Regulatory
    Permanent employment
    Full time
    Work at office
    Work from home
    Worldwide

    Moderna Therapeutics

    Somerville, MA
    2 days ago
  • $169.4k - $266.2k

     ...and aligned with medical strategy. Your work will...  ...scientific exchange across global audiences. You will be...  ...way. You will also help drive innovation by applying...  ...engagement objectives. Lead scientific content development...  ...with Legal and Regulatory colleagues to support accurate... 
    Regulatory
    Minimum wage
    Full time
    Local area

    Takeda Pharmaceutical Co.

    Cambridge, MA
    17 hours ago
  • $169.4k - $266.2k

     ...and aligned with medical strategy. Your work will...  ...scientific exchange across global audiences. You will be...  ...way. You will also help drive innovation by applying...  ...engagement objectives. Lead scientific content development...  ...with Legal and Regulatory colleagues to support accurate... 
    Regulatory
    Minimum wage
    Full time
    Local area
    Worldwide

    Takeda Pharmaceutical Co.

    Kendall Square, MA
    1 day ago
  • $169.4k - $266.2k

     ...and aligned with medical strategy. Your work will...  ...scientific exchange across global audiences. You will be...  ...way. You will also help drive innovation by applying...  ...engagement objectives. Lead scientific content development...  ...with Legal and Regulatory colleagues to support accurate... 
    Regulatory
    Minimum wage
    Full time
    Local area
    Worldwide

    Takeda Pharmaceutical Co.

    Kendall Square, MA
    1 day ago
  • $295k - $380k

     ...Reports to: VP/Head of Global Medical Affairs,...  ...Global Medical Lead (GML), Neurometabolic...  ...global medical strategy, evidence generation...  ..., this individual drives integrated medical...  ..., Biometrics, Regulatory Affairs, Value & Access...  ...Post-approval evidence generation... 
    Regulatory
    Local area
    Remote work
    Worldwide

    ITF Therapeutics LLC

    Concord, MA
    17 hours ago
  • $232.5k - $320k

    ## Global Brand Lead, NavtemadlinPostuler: Cambridge (US): Temps complet:...  ...shaping and delivering the brand strategy for Navtemadlin, a Phase 3...  ...Medical, Market Access, Regulatory, Insights, Finance, Supply,...  ...on US market requirements.* Drive lifecycle management strategies... 
    Regulatory
    Temporary work
    Local area
    Flexible hours

    Ipsen

    Cambridge, MA
    1 day ago
  • $212k - $333.19k

     ...and supporting disease area strategy and early asset commercial...  ...scientific, clinical, regulatory, and competitive insights...  ...creation.This leader will drive cross-functional efforts to...  ...a demonstrated ability to lead in a highly matrixed global environment. You will report... 
    Regulatory
    Minimum wage
    Local area
    Remote work

    Takeda

    Cambridge, MA
    17 hours ago
  • $192.4k - $302.39k

     ...shine? Join us as a Director, Global Medical Lead, Zasocitinib- Psoriatic...  ...optimization of the global medical strategy for zasocitinib in PsA, in...  ...local practice, access, regulatory, and stakeholder needs....  ...senior medical review and approval input for global scientific... 
    Regulatory
    Minimum wage
    Work at office
    Local area
    Remote work

    Takeda

    Somerville, MA
    1 day ago
  • $154.4k - $242.55k

     ...as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU based...  ...of translational biomarker strategies across preclinical and clinical...  ...biomarker data to drive program decision-making. Evaluate...  ...and documents submitted to Regulatory Agencies.• Establish and... 
    Regulatory
    Minimum wage
    Local area

    Takeda

    Boston, MA
    17 hours ago
  • $120k - $180k

     ...own destiny.Klaviyo is looking for a Global Services Operations Lead to join our Customer Experience...  ...Salesforce, Tableau, Snowflake, and driving process improvements without a team...  ...and initiatives for Global Services Strategy & Operations, balancing multiple short... 
    Temporary work
    Shift work

    Klaviyo

    Boston, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Lead — Drive Global Approvals & Strategy. Be the first to apply!