- 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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Sumitomo Pharma (Providence, RI)
- … 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
- 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 (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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… 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