- 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 ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) driving...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… 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 ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Sanofi Group (Framingham, MA)
- …setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures alignment and communication internally and ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** :...teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices … more
- Candela Corporation (Marlborough, MA)
- …MA** State/Territory **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product ... personal relationships even in heated or difficult/dynamic circumstances. . Global accountability for Design/Supplier Quality performance, Sterilization/ Labeling … more
- Amgen (Cambridge, MA)
- …processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices , disposables, and the associated GMP/ Device documentation and regulatory ... Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's… more
- GRAIL (Boston, MA)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual… more
- Sanofi Group (Cambridge, MA)
- …relationships with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… 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
- Evident Scientific (Needham, MA)
- …operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, the ... alignment. + Align strategies and ensure consistency of technical documentation, labeling , and registration activities. + Contribute to global regulatory… more
- Bristol Myers Squibb (Devens, MA)
- …+ Perform Power Studies that include Fault Current calculations, Protective Device /Relay evaluations and setting selection, and Arc Flash Analysis and maintenance ... of Incident Energy equipment labeling . + Perform review of electric rooms and maintain...delays and financial impact. + Position is supervised by Director , Utilities & Sustainability. Daily direction and alignment is… more