- 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:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... progress. The Associate Director , Global Regulatory Affairs - Global Labeling ... function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements (FDA,… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...as the Regulatory reviewer for assigned products. This position is responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership ... is true to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical**… 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...are established and maintained. + Provides input into the global organization for labeling strategies of marketed… more
- BeOne Medicines (Cambridge, MA)
- …expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assess impact of changes on business and ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA,...+ Facilitate policy and development of standard interpretation of global regulation. + Trains, develops, and manages an effective… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Managesanyreportingstaff(Takeda employeesand/orcontractors). + Preparesorsupervisespreparationofhigh-quality DP-CMCsectionsfor Global regulatory filings to ... knowledge. **Job Description** **Objective:** Under the direction of the Director or Sr. Director , ODPD, the Assoc....knowledge of current GMP regulations. + Detailed knowledge of Global regulatory requirements for drug products. +… 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 (Cambridge, MA)
- …influencing abilities Knowledge + Rheumatology or Immunology area knowledge desired + Regional/ global Regulatory requirements + GCP/ICH **TRAVEL ... you to shine? Join us as an Executive Medical Director in our GI2 Therapeutic Area Unit in our...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… 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)
- …+ Engage directly with regulatory agencies, representing clinical pharmacology in global regulatory meetings; contribute to regulatory deliverables, such ... understanding of Phase I clinical operations, drug development processes, and global regulatory requirements. + Advanced knowledge of clinical pharmacology,… 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)
- …and simulation activities as appropriate for the project. + Contribute to regulatory documents including Investigator Brochures, Labeling and those required for ... is true to the best of my knowledge. **Job Description** ** Director , Clinical Pharmacology** **Cambridge, MA** **Hybrid** **Job Posting Description** The PDT… 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
- Rhythm Pharmaceuticals (Boston, MA)
- …as required. + Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA, NDA, MAA etc). Qualifications and Skills + ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the...to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product… more
- Cardinal Health (Boston, MA)
- …activities touching commercialization campaigns, supply and demand alignment, quality and regulatory , labeling , product availability, customer support, and voice ... customer loyalty, sales growth and improved profitability. **_Job Summary_** The Global Product Manager is responsible for the core product management activities… more