- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... NDA, 510K, CE Mark submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global… more
- Mohawk Valley Health System (Utica, NY)
- …Job Summary The Senior Director of Quality Management Systems and Regulatory Affairs is responsible for establishing and promoting quality outcome standards ... the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and executing large scale… more
- Organon & Co. (Jersey City, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new legislations, guidelines and ... Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global Therapeutic Area Leader (GTAL),...entire life cycle of the drug. + Represent Global Regulatory Affairs within our company's internal committees… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises expertise in the ... degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas of at least 14… 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:** + Plan, ... and product development meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global… more
- Unilever (El Segundo, CA)
- …infinite supply of Liquid IV for extraordinary hydration. **About the Role:** The Director of Regulatory Affairs leads the Regulatory Affairs team and ... company. + Team Development & Leadership: Lead, mentor, and cultivate a high-performing Regulatory Affairs team with a strong emphasis on leadership development,… more
- IQVIA (Columbia, MD)
- MCRA an IQVIA business is seeking an Director, Cardiovascular Regulatory Affairs to be a critical team member supporting regulatory strategy and submissions ... preferred. + Previous or current agency experience is required. + 7+ years of regulatory affairs experience required. + 4+ years of cardiovascular medical device… more
- Edwards Lifesciences (Las Vegas, NV)
- Patients are at the heart of everything we do. As the Senior Director, THV Medical Affairs , you will drive strategy development, evidence generation initiatives, ... and scientific communication activities to advance key organizational objectives that...vision of the organization + Facilitating effective collaboration across senior leadership stakeholders, including clinical, regulatory , marketing,… more
- BeOne Medicines (San Mateo, CA)
- …We currently have an exciting opportunity available for an experienced Senior Director, Investigator-Initiated Trials (IIT) and Expanded Access Programs in Global ... Medical Affairs . The ideal candidate will be responsible for effective...non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program… more
- Sanofi Group (Morristown, NJ)
- **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