- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …PDM functions including Product and Portfolio Strategy, Global Manufacturing,Supply Chain, Regulatory CMC , and the wider Quality organization to achieve ... procedures to ensure compliance withGxPstandards, corporate policies, FDA, EMA,and other regulatory body regulations and guidelines. + Set and drive compliance to… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep knowledge of ... and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …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
- 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
- AbbVie (North Chicago, IL)
- …medicines. In the course of our work, we collaborate with early-stage CMC , Quality Assurance, Regulatory Affairs, Internal and External Manufacturing, and ... discipline. + Effective writer and communicator of research or other regulatory materials. Additional Information Applicable only to applicants applying to a… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the preparation, review, and approval of standard procedures. + Review regulatory CMC submissions including analytical procedures, method validations, reference ... standards, batch analyses, product characterization, stability, and specification sections. + Identify, review, and organize analytical documents to support robust analytical method life-cycle management. + Finalize purchase requisitions and contracts with… more