- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… 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:** + ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee...where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be… more
- Tecomet (Woburn, MA)
- …Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior Director of Quality Assurance and Regulatory Affairs ... sites to encompass global Quality Systems and Regulatory Affairs responsibilities. + May have Senior Managers and Directors reporting in a region. + Performs… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- We are seeking a Senior Director , Federal Government Affairs to lead our US federal government engagement in Washington, DC. This position reports to the ... the strategic leader, and a member of the Government Affairs Leadership Team, the Senior Director...Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to… more
- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- BeOne Medicines (Cambridge, MA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory ... direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
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