- AstraZeneca (Boston, MA)
- Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of ... global regulatory strategies for all assigned products...and procedural/operational issues as they arise. Actively collaborate with Senior Management and Enterprise functions (eg Clinical, Commercial, Medical… more
- Ipsen (Cambridge, MA)
- Title: Associate Director , Gross-To-Net (GTN) Accounting & Forecasting Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global ... Supported by nearly 100 years of development experience, with global hubs in the US, France and the UK,...About the Role As the experienced and results-driven Associate Director of Gross-to-Net Forecasting and Reporting , you will… more
- Bayer (Cambridge, MA)
- …of brilliant and diverse minds to make a real difference, there's only one choice.** ** Senior Director , Global Regulatory Leader-IVD** The Senior ... **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Director , Global Regulatory Leader-IVD are to: **Develop… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience...success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting ... Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's… more
- CBRE (Boston, MA)
- Business Development Senior Director , Global Occupier Accounts Job ID 210942 Posted 02-May-2025 Service line GWS Segment Role type Full-time Areas of ... Senior Managing Director , Business Development** The Senior Business Development Director , Global ... executives. + Possess a sufficient understanding of healthcare regulatory compliance, including, but not limited to, TJC, DNV,… more
- Takeda Pharmaceuticals (Boston, MA)
- …technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for ... activities in support of domestic and international clinical development initiatives. The Senior Director , GCD works in a multidisciplinary matrix environment… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic ... of your future at Takeda. Join us as a Senior Medical Director - GI & Inflammation- Rheumatology,...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to mechanism of action . Preferably with expertise Neurology or Psychiatry . Regional/ global Regulatory requirements . GCP/ICH . Emerging research in designated ... of your future at Takeda. Join us as a Senior Medical Director , Clinical Science Neuroscience, Sleep...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… 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)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... and empower you to shine? Join us as a Senior Medical Director , Oncology Clinical Science in...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Sanofi Group (Cambridge, MA)
- …products, departmental activities, and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance and ... **Job Title:** Director , US Regulatory Affairs - Advertising...helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Clinical Research Director , Ophthalmology **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future ... be critical in helping our teams accelerate progress. The Senior Clinical Research Director (CRD) is an...development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other… more
- BeOne Medicines (Cambridge, MA)
- …and to 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Director , Radioligand Therapy Delivery and Customer Service **Location:** Cambridge, MA **About the Job** Sanofi Oncology is pioneering the ... timely, and seamless delivery of this time-sensitive therapy, we are seeking a **US/ Global Director , Radioligand Therapy (RLT) Delivery & Customer Services** .… more
