- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...medical device, including some supervisory and/or leadership experience. + Associate Manager : Requires 6+ years of relevant… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a...determined based on qualifications relevant to the role. + Associate Manager : Requires 6+ years of relevant… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences...bachelors in Chemistry, Biology or related field, and + Associate Manager : Requires 6+ years of relevant ... regulatory submission work across multiple clinical programs and/or submissions. As a Manager , CMC Regulatory Sciences , a typical day might include the… more
- Teva Pharmaceuticals (West Chester, PA)
- …position comes with 4 direct reports (Dir, Sr Manager , Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for ... at Teva (both development and marketed products) ⦁ Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Manager (AM), Regulatory Information Management (RIM) will serve as the global knowledge-center for the Regulatory ... the BeiGene RIM system as the authoritative source for regulatory data. The AM will ensure compliance with all...data standards. This role which reporting to the Senior Manager RIMT is a critical member of the RIM… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. + ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- University of Colorado (Aurora, CO)
- QA Senior Manager - 33670 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Biomanufacturing Center** **Job ... Title: QA Senior Manager ** **Position #: 00803572 - Requisition #:33670** **Job Summary:**...three direct and four indirect reports, including Quality Assurance Associate Is and IIs. + Recruit, supervise, develop, and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The **Sr Manager , Clinical Drug Supply & Logistics** is responsible...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more
