- Pfizer (Parsippany, NJ)
- …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the ... help Pfizer develop and implement chemistry, manufacturing and control ( CMC ) regulatory strategies for small and large...of pending registrations and respond to queries. As a Manager , you provide guidance to operational teams for managing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy ...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we are** ... SOPs (Standard Operating Procedure) and requirements as applicable. Assist in providing regulatory strategy for assigned R&D projects to R&D, and applicable… more
- Merck (Rahway, NJ)
- …Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... 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