- Kelly Services (Winston Salem, NC)
- **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to...( CMC ) compliance and documentation activities. This fully remote role is ideal for a regulatory … more
- Bausch Health (Bridgewater, NJ)
- …+ Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory ... and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ regulatory … more
- ThermoFisher Scientific (Wilmington, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... role is for the **North America region** and is remote based. This role provides real world expertise to...in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing… more
- Merck (West Point, PA)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail ... to meet USP's objectives and to support continued growth. **This is a mostly remote role that requires mandatory 1-2x a month visits to the Rockville, MD… more
- University of Rochester (Albany, NY)
- …supervision, office workflows, accounts receivable collaboration, payer rules, compliance, and regulatory requirements. The Assistant Coding Manager must exhibit ... to all and is a place where all can thrive. **Job Location (Full Address):** Remote Work - New York, Albany, New York, United States of America, 12224 **Opening:**… more
- Bristol Myers Squibb (Summit, NJ)
- …re-engaging the body's immune system to treat cancer. We are looking for a Manager / Senior Engineer to join the Breyanzi Product Stewardship Cell Therapy Technical ... at a global level. This highly cross-functional role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement,… more
- Merck (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
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