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

Global Regulatory Strategist — Lead HA Strategy & Submissions

BioSpace

Sanofi Inc. in Morristown, NJ and Cambridge, MA is seeking a Regulatory Strategist to shape global regulatory strategy for assigned projects, including Health Authority interactions, across US, EU, and international programs. As a key member of the Global Regulatory Team (GRT), you will provide regulatory input, lead briefing documents, manage timelines, and coordinate submissions (NDA/BLA/MAA, IND/CTA) with cross‑functional partners. #J-18808-Ljbffr BioSpace

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Strategist — Lead HA Strategy & Submissions in Convent Station, NJ vacancy
  • Sanofi is seeking a Regulatory Strategist to lead the development and execution of regulatory strategies in Morristown, NJ. You will work within the R&D team to support submissions and ensure compliance with US, EU, and global requirements. The ideal candidate has a scientific... 
    Regulatory
    Full time

    Sanofi

    Convent Station, NJ
    2 days ago
  • Sanofi in Morristown, NJ seeks a Global Submission Manager to oversee global regulatory submissions within the GRA portfolio. You will coordinate with Global Regulatory Teams, Submission Leads, and cross‑functional colleagues to plan, execute submissions in alignment with... 
    Regulatory

    Sanofi

    Convent Station, NJ
    3 days ago
  • Sanofi is seeking a Global Submission Manager in Morristown, NJ to manage all submission types for the GRA portfolio. The role includes representing GRO on Global Regulatory Teams, prioritizing workload, and negotiating timelines with stakeholders. Close collaboration with... 
    Regulatory

    Sanofi EU

    Convent Station, NJ
    4 days ago
  •  ...seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs...  ...role involves supporting the global product team in developing registration strategies for product approvals in...  ...leveraging their expertise, manage submissions, and develop timelines in... 
    Regulatory

    HUTCHMED

    Florham Park, NJ
    4 days ago
  • Global Regulatory Strategist Job title: Global Regulatory Strategist Location...  ...regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in...  .... Health Authority (HA) Engagement...  ...as needed. Regulatory Submissions & Operations Leads submission... 
    Regulatory
    Local area

    Sanofi

    Convent Station, NJ
    3 days ago
  • About the job As the Global Regulatory Lead on our Global Regulatory...  ...global regulatory strategies for their products in...  ...Strategy (GRPS), Global Submission Strategy, and core...  ...a team of Regulatory Strategists (RS) as appropriate....  ...development of global HA interaction plan and... 
    Regulatory

    Sanofi

    Convent Station, NJ
    1 day ago
  • BioSpace is hiring a GRA CMC Lead in Morristown, NJ. In this role, you will manage CMC regulatory strategies and work closely with health authorities, ensuring compliance...  ...regulatory experience, and the ability to navigate global regulations. The position offers a... 
    Regulatory

    BioSpace

    Convent Station, NJ
    2 days ago
  • Sanofi is seeking a Global Regulatory Lead in Morristown, NJ, responsible for developing and executing global regulatory strategies for oncology products. Candidates should have significant regulatory affairs experience along with investigative and strategic thinking skills... 
    Regulatory

    Sanofi

    Convent Station, NJ
    1 day ago
  • EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal... 
    Regulatory

    EmergencyMD

    Convent Station, NJ
    1 day ago
  • Eacademy Sanofi in Morristown, NJ is seeking a GRA CMC Lead to manage regulatory strategies for the R&D team. This role involves direct interaction with...  ...sector. Join our innovative team to bring life-changing medicines to patients globally. #J-18808-Ljbffr Eacademy Sanofi
    Regulatory

    Eacademy Sanofi

    Convent Station, NJ
    3 days ago
  • Sanofi in Morristown, NJ seeks a Platform Lead for Regulatory Strategy and Continuous Improvement, coordinating cross-functional programs across global regulatory landscapes in CMC and device areas. You will establish global responsibilities, build governance structures... 
    Regulatory

    Sanofi

    Convent Station, NJ
    1 day ago
  • Sanofi Morristown seeks a Regulatory Strategy & Continuous Improvement - Platform Lead to steer global CMC/Device regulatory activities. You will lead multiple cross-functional programs, align project objectives with strategy, and drive change management across interconnected... 
    Regulatory

    SwiftCruit

    Convent Station, NJ
    4 days ago
  • A leading software development company based in New Jersey is seeking a professional in Global Medical Affairs. This role requires accountability for deliverables, including...  ...sound medical rationale and support regulatory submissions. Join us to make a significant impact... 
    Regulatory

    360 IT Professionals

    Madison, NJ
    4 days ago
  •  ...Morristown, NJ and Cambridge, MA, is seeking a Global Regulatory Strategist to drive regulatory product strategies in oncology. You will lead cross‑functional teams, develop...  ...Health Authorities, and oversee regulatory submissions and expedited pathways to support timely... 
    Regulatory

    BioSpace

    Convent Station, NJ
    1 day ago
  • $150k - $180k

    Emerson in Florham Park, NJ, is looking for a Global Trade Compliance Director to lead regulatory and compliance strategies across their Fluid and Motion Control businesses. This role requires strong leadership in managing trade compliance and developing effective international... 
    Regulatory

    Emerson

    Florham Park, NJ
    4 days ago
  •  ...Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned assets. The...  ...and program teams to deliver submission-ready CMC content with a risk...  ...approach. Responsibilities include leading global CMC strategies,... 
    Regulatory

    Shionogi Inc.

    Florham Park, NJ
    1 day ago
  •  ...in Morristown, NJ. In this role, you will contribute to global regulatory strategies for medical device and combination products, collaborating...  ...landscapes. The role includes preparing high-quality regulatory submissions and supporting compliance activities. Join us to make a... 
    Regulatory
    Worldwide

    Eacademy Sanofi

    Convent Station, NJ
    4 days ago
  • $127k - $170.5k

     ...products to consumers worldwide. Serve as a Global Regulatory CMC Lead within the Global Regulatory CMC Team...  ...teams to support regulatory strategy and execution. Maintain compliance while...  ...timelines Manage regulatory submissions across major markets (FDA, EU, etc.)... 
    Regulatory
    Worldwide

    (1023) Chattem, Inc

    Convent Station, NJ
    1 day ago
  • $148.5k - $214.5k

    Job Title Regulatory Strategist Location Morristown, NJ / Cambridge, MA...  ...by defining and executing global regulatory strategies for assigned projects. You...  ...regulatory requirements, lead Health Authority (HA) interactions, and support submissions such as NDA/BLA/MAA, IND/... 
    Regulatory
    Full time
    Local area

    Sanofi

    Convent Station, NJ
    1 day ago
  • Job title: Regulatory Strategist Location: Morristown,...  ...key member of the Global Regulatory Team (...  ...Global Regulatory Lead (GRL), you will...  ...global regulatory strategy and drive the execution...  ...Authority (HA) interactions. You...  .... Leads submission team or regulatory... 
    Regulatory
    Local area

    BioSpace

    Convent Station, NJ
    1 day ago
  • $150k - $200k

    Givaudan Fragrances in East Hanover, NJ, is seeking a Head of Regulatory Systems Strategy to lead compliance innovation within the Fragrance & Beauty divisions. This role requires an experienced professional to drive complex projects and facilitate cross-functional collaboration... 
    Regulatory

    Givaudan Fragrances

    East Hanover, NJ
    4 days ago
  • Bristol Myers Squibb is seeking a Director, US Regulatory Lead to oversee regulatory strategy and execution for the Immunology and Cardiovascular therapeutic...  ...manage Health Authority interactions and lead NDA submissions. With responsibilities that include providing... 
    Regulatory

    Bristol Myers Squibb

    Madison, NJ
    4 days ago
  • Sanofi Inc. seeks a Regulatory Strategy & Continuous Improvement Platform Lead in Morristown, NJ. You will guide global regulatory activities, build governance structures, and drive cross-functional alignment across GRA CMC and GRA Device teams. You will manage multiple... 
    Regulatory

    BioSpace

    Convent Station, NJ
    1 day ago
  • $150.8k - $226.2k

     ..."be an innovative global healthcare company...  ...implementation of the quality strategy closely aligned...  ...late ICSR submission of reports, and...  .... Ensure adequate regulatory inspection and audits...  .../Audits. Lead in a proactive and...  ...line with worldwide HA requirements are implemented... 
    Regulatory
    Local area
    Worldwide

    Daiichi Sankyo US

    Basking Ridge, NJ
    4 days ago
  • Job Title Global Head of Clinical Data and Business Strategy Location Morristown, NJ or Cambridge, MA About The...  ...clinical databases supporting regulatory submissions. We seek an exceptional leader...  ...development and the proven ability to lead transformational change through... 
    Regulatory

    BioSpace

    Convent Station, NJ
    4 days ago
  • $148.5k - $214.5k

    Job Title: Regulatory Strategy & Continuous Improvement - Platform Lead Location: Morristown, NJ Overview As the Platform Lead within our R&D team, you will spearhead...  ...coordinating multiple concurrent programs across global regulatory landscapes. You will establish global... 
    Regulatory
    Worldwide

    Sanofi

    Convent Station, NJ
    4 days ago
  • Daiichi Sankyo, Inc. is seeking an Executive Director for Oncology R&D, Global Clinical Lead, to oversee multi-program development and strategic regulatory submissions. The role drives clinical strategy, partners with CROs and senior management, and aligns development... 
    Regulatory

    Daiichi Sankyo

    Basking Ridge, NJ
    4 days ago
  • $240.94k - $291.96k

     ...Position Director, US Regulatory Lead, GRS Position Summary The...  ...will oversee regulatory strategy and execution for Immunology...  ...Health Authority (HA) interactions along including upcoming NDA submission. The incumbent may also serve as Global Regulatory Lead (GRL)/USRL... 
    Regulatory
    Full time
    Temporary work
    Remote work

    Bristol Myers Squibb

    Madison, NJ
    4 days ago
  •  .... seeks a senior clinical development leader to oversee global programs and lead regulatory strategy across multiple Phase II/III studies. You will ensure CRO performance and provide medical input into submissions, translational medicine, and biomarker plans. You will represent... 
    Regulatory

    Merck & Co.

    Basking Ridge, NJ
    13 hours ago
  • Job Title AI Enablement and Adoption Lead, Strategy and Operations, Specialty Care GBU Location...  ...they use by habit. Reporting to the Global Head of Strategy & Operations,...  ...new ways of working respect the GBU’s regulatory, privacy, data‑protection, and information... 
    Regulatory
    Work at office
    3 days per week

    Sanofi

    Convent Station, NJ
    13 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Strategist — Lead HA Strategy & Submissions. Be the first to apply!