- Sanofi (Cambridge, MA)
- Job Title: Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs - Advertising and...FDA are established and maintained. Provides input into the global organization for labeling strategies of marketed… 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
- Sanofi Group (Cambridge, 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
- Candela Corporation (Marlborough, MA)
- …personal relationships even in heated or difficult/dynamic circumstances. . Global accountability for Design/Supplier Quality performance, Sterilization/ Labeling ... **Sr. Director , Design and Supplier Quality** Requisition Number **2882**...regulatory / compliance. . Working understanding of relevant global /regional medical device regulations and standards with particular emphasis… 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)
- …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
- Evident Scientific (Needham, MA)
- …operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, ... documentation, labeling , and registration activities. + Contribute to global regulatory strategy discussions, providing US compliance insights. **Leadership… 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
