- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling...for the device regulatory strategy, including a global labeling strategy + Ensures alignment and… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs - Advertising and...are established and maintained. + Provides input into the global organization for labeling strategies of marketed… more
- GRAIL (Boston, MA)
- … plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Knowledge** + Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of action + Knowledge of Hematology and/or Rare Disease is desirable + Regional/ global Regulatory requirements + Emerging research in designated therapeutic area ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge + Pulmonologist/Neurologist with sleep medicine expertise + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in ... Medical Director leads and drives strategy for the overall global (US/EU/Japan/China) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more