- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory Sciences ... must hold a BS/BA degree in a scientific discipline. Advanced degree preferred. + CMC Regulatory Sciences Specialist : 2 years of relevant experience in a… more
- Atlantic Health System (Pompton Plains, NJ)
- …the appropriate department channels, ie contacts hotline to troubleshoot with a specialist when necessary to resolve the issue or set-up service when appropriate. ... revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP,… more
- Actalent (Grand Rapids, MI)
- …requirements to stakeholders to maintain compliance without business delays. + Provide regulatory CMC support, including document preparation for filings and ... Title: Regulatory Affairs SpecialistJob Description The Senior Regulatory Affairs Specialist /Compliance Specialist /QA ...for INDs, ANDAs, NDAs, and more. + Knowledge in regulatory science and submission data requirements for… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist ** Kelly Science and Clinical is seeking a ** Regulatory Affairs Specialist ** **for** our client a leading medical ... **Responsibilities** + Provide support for the execution of the pharmaceutical regulatory strategy and submissions for assigned products: Provide support for… more
- Sanofi Group (Framingham, MA)
- …and CMC requirements. The role will provide scientific expertise supporting CMC regulatory guidance with innovative approaches to process and analytical ... and global CMC projects. + 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions.… more
- Guidehouse (St. Louis, MO)
- …Ability to Obtain Public Trust We are currently searching for a Quality Assurance Specialist to provide support to the US Food & Drug Administration in the following ... other established guidelines for the Chemistry Manufacturing and Controls ( CMC ) Review Process. + Coordinate the resolution of OPQ...Will Need** **:** + A bachelor's degree in Life Sciences or a relevant field such as Quality Assurance,… more
- Parexel (Harrisburg, PA)
- …are looking to fill a **Scientist 2 or 3 - Analytical Chemist Metrology Specialist ** position working as a full-time employee of Parexel FSP on long-term assignment ... position does not offer sponsorship** . **The Analytical Chemist Metrology Specialist is responsible for the oversight of regulated and non-regulated laboratory… more
- ERP International (Cherry Point, NC)
- …ERP International, LLC:** ERP is a nationally respected provider of health, science , and technology solutions supporting clients in the government and commercial ... Maintain adherence to the Joint Commission, URAC, CMSA, DHA and other regulatory requirements. Apply medical care criteria (eg, InterQual). * Establish cost… more