- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC Regulatory Sciences team. We are seeking a highly ... the CMC aspects (eg, Module 3) of submission content. As a Staff CMC Regulatory Sciences Specialist . a typical day might include the following: +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Specialist II, US Product CMC Regulatory Affairs supports the ... maintenance, change management activities, and compliance related tasks. **Duties & Responsibilities** Regulatory Lifecycle Management: + Supports LRL CMC RA in… more
- Atlantic Health System (Pompton Plains, NJ)
- …the appropriate department channels, ie contacts hotline to troubleshoot with a specialist when necessary to resolve the issue or set-up service when appropriate. ... revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP,… more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... Sr. Specialist , Regulatory Project Management (Evergreen Posting)...**Basic Qualifications:** + Education: Bachelor's or Master's degree in science , engineering, or related discipline + Experience:Bachelor's with 5… more
- Eurofins (Lancaster, PA)
- …GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical ... validation and quality control. Position Summary Do you love science and innovation but do not want to work...is seeking a driven and enthusiastic Inside Business Development Specialist . This role is a fantastic way to kick… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing ... Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.... inspections. + Effective teamwork and communication with the CMC sub teams to ensure all API and drug… more
- BeiGene (Emeryville, CA)
- …+ Monitors regulatory agencies and industry standards for data related regulatory requirements (eg: IDMP, PQ- CMC , DADI etc..), and changes and version ... with cross functional teams (RA, IT, QA etc.). The Specialist /. Sr.Specilaist Data Management and Governance is responsible for...3+ years of experience in Pharmaceutical, Biotechnology, or Life Sciences , with a specific focus in Regulatory … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve ... internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and… more