- Lilly (Indianapolis, IN)
- …Purpose: The purpose of the Senior Director/Executive Director, Global Regulatory Affairs, Global Regulatory Lead ( GRL ) role is to develop and ... requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central...Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in… more
- Sanofi Group (Bridgewater, NJ)
- …** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The Global Regulatory Affairs Lead ( GRL ) is the fully accountable decision maker for ... the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in...GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate + The GRL… more
- Sanofi Group (Swiftwater, PA)
- …RSV disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead ( GRL ). We are an innovative ... teams to ensure the delivery of business objectives. + The RS enables the Global Regulatory Lead ( GRL ) to provide regulatory position to… more
- AbbVie (Irvine, CA)
- …Responsible for development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead ( GRL ) and project team. Plans ... in-depth understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides … more
- Sanofi Group (Cambridge, MA)
- …key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead ( GRL ), you will leverage your regulatory ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive...governance, and committees + May serve as a regional/local regulatory lead and point of contact with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead ( GRL ), US regulatory lead ... cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions + Support GRL with scheduling regulatory … more
- AbbVie (Madison, NJ)
- …product(s) with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead ( GRL ), Associate Director, or ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / Florham Park… more
- AbbVie (Boston, MA)
- …products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead ( GRL , Director), in the development ... Instagram, YouTube and LinkedIn. Job Description The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development… more
- Takeda Pharmaceuticals (Boston, MA)
- …Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead ( GRL ) in preparations and timely ... Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA with the following… more
- AbbVie (Irvine, CA)
- …device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead ( GRL ) and project team. Plans and ... in-depth understanding of regulations for device products, leads and participates in global regulatory product teams, interprets regulations, and provides … more
- Teva Pharmaceuticals (West Chester, PA)
- …Director, Regulatory Affairs you will be responsible for acting as and supporting the Global Regulatory Lead ( GRL ) in strategic vision and innovative ... strategy for biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to… more
- Taiho Oncology (Princeton, NJ)
- …to lead one or two high priority late-phase clinical development programs as Global Regulatory Lead ( GRL ), responsible for leading regulatory ... with the US Food and Drug Administration (FDA). + Lead /support Regulatory subteam(s) for assigned projects to...and other product-related teams. Foster and facilitate communication with Global Regulatory Affairs on these topics, including… more
- AbbVie (South San Francisco, CA)
- … HA requirements. + Responsible for products within a Therapeutic Area & support the Global Regulatory Lead ( GRL ) & Therapeutic Area Head with ... YouTube and LinkedIn. Job Description Key Responsibilities + Responsible for providing regulatory strategy & support for global development. + Responsible for… more
- AbbVie (Chicago, IL)
- …products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead ( GRL , Director), in the development ... Instagram, YouTube and LinkedIn. Job Description The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development… more
- J&J Family of Companies (Trenton, NJ)
- Director, Global Regulatory Leader ( GRL ) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director, Global ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role + 7 or More… more
- Sanofi Group (Cambridge, MA)
- …input on the TPP, business planning, governance and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic ... of the GRL + Contributes to the Global Regulatory Team (GRT) for assigned projects...study team meetings) + May serve as a regional/local regulatory lead and point of contact with… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director, Global Regulatory Lead , is responsible for developing and ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead ...GRL or TA Head. May participate in or lead regulatory and Company initiatives. Based on… more
- Merck (Upper Gwynedd, PA)
- …Experience with Learn/ Lead /Listen (L3 Next) or other strategic frameworks + Global experience + Knowledge of Company commercial, regulatory , and legal ... tumor team franchise strategies across multiple products + Execute GRL interviews to begin change management process and support...of deliverables for markets + Partner closely with Global Tumor/Brand teams to assimilate L3 Next outputs to… more
- CSL Behring (King Of Prussia, PA)
- …high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) ( Global Product Strategy or ... Hybrid role. You will report to the Director, Regional Regulatory TA Lead . **RESPONSIBILITIES:** + You will...any post MA submissions. + You will contribute regional regulatory perspective to the global regulatory… more