- Merck (Rahway, NJ)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality to achieve ... with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines. + Set and drive...+ Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed. +… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... TJC, OSHA. 5. Maintains clear, real time communications shift-to-shift and with leadership regarding issues, concerns and problems which may affect patient care or the operation of the department. 6. Participates in planning and implementing change through… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Cambrex High Point (High Point, NC)
- …of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions and help them develop ... and manufacturing. Ensure compliance with applicable Company SOPs and regulatory guidances . Perform laboratory investigations and non-routine project work… more
- Merck (Wilson, NC)
- …(Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory - CMC , and Supply Chain, etc.) **Minimum Education Requirements ... other TT teams. + Required to comply with our Company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance… more
- Cambrex High Point (Minneapolis, MN)
- …understanding of the industrial regulatory landscape; Good understanding of site SOPS, regulatory + CMC concerns and can answer client questions and help ... cross-functional technical departments, including organic chemistry and engineering. + GMP/ Regulatory Knowledge: Strong understanding of the GMP landscape and… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …effectively with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, Regulatory CMC , and other key functions to align on ... will be at the interface of development, manufacturing, and regulatory , shaping robust, scalable processes and ensuring they are...of drug product and packaging processes in line with regulatory and Takeda standards. + Act as part of… more
- Lilly (Boston, MA)
- …Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings + Review and provide technical ... feedback on internal and external collaborators' experimental designs and results. + Participate actively in technical discussions and meetings, proactively communicate technical findings and results to stakeholders, train and support teammates as needed. +… more
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