- AbbVie (Waltham, MA)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and qualifications are as follows: **Responsibilities:** + Provides support for designated regional regulatory activities for PDM CMC Project and Commercial ... Teams, Regulatory Project and Regulatory Submissions Teams, with focus on Small/Synthetic Molecules. +...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and … more
- Sanofi Group (Morristown, NJ)
- …in eCTD format. + Ensure all CMC documentation is accurate, aligned with project objectives, and compliant with regulatory guidelines. + Serve as CMC ... **Job Title:** Manager , CMC Development and Dossiers **Location**...with technical project support, manufacturing, quality, or CMC dossiers for regulatory submissions (eg, Module… more
- Charles River Laboratories (Rockville, MD)
- …help you build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. ... mapping resource across projects. In this role, the Senior CMC Project Manager is the...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Abeona (Cleveland, OH)
- Position Overview We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic execution of multiple ... commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- University of Colorado (Aurora, CO)
- ** Project Manager III** **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Institute** **Job Title:** ** Project ... reserved. Posted by the FREE value-added recruitment advertising agency (https://www.jobelephant.com/) Project Manager III - 37355 University Staff This… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more