- 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 (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...mentoring team members is preferred. + Strong knowledge of global regulatory labeling requirements (FDA,… 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
- Sumitomo Pharma (Boston, MA)
- …experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based ... the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory...support the successful submission and achievement of target product labeling + Accountable in conjunction with the GRL for… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or… 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
- AbbVie (Waltham, MA)
- …consortiums, key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer ... collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies. He / She serves as a… more
- Sanofi Group (Cambridge, MA)
- …team on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures ... **Job Title:** GRA Device Lead (Associate Director ) **Location:** Cambridge, MA/ Morristown, NJ **About the...be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Amgen (Cambridge, MA)
- …and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, ... key messages relative to diverse audience requirements + Knowledge of applicable global regulatory requirements. Experience preparing technical sections of … more
- Takeda Pharmaceuticals (Boston, MA)
- …they value scientific excellence. + Represents Clinical Pharmacology in meetings with global regulatory agencies for his/her assigned programs. + Participates as ... that will inspire you and empower you to shine? Join us as Senior Director , Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda, we are… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the Global Medical Safety ... Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Lilly (Boston, MA)
- …pharmaceutical organizations on genetic medicine-specific legal challenges, including global regulatory submissions, manufacturing and distribution complexities, ... innovative, multinational pharmaceutical companies, including, but not limited to: global product development, registration, and commercialization; FDA labeling … more