- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
- Amgen (Washington, DC)
- …reach over 10 million patients worldwide. It's time for a career you can be proud of. Regulatory Affairs CMC Senior Manager **Live** **What you will do** ... The CMC Regulatory Senior Manager is responsible for execution...+ Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff +… more
- Amgen (Holly Springs, NC)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and...**Operational Excellence Departmental Process Management** + Partners with other GRA- CMC Sr . Directors to ensure that internal… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... **What you will do** Let's do this. Let's change the world.The Regulatory Affairs Manager CMC Contributes to product teams and acts as product lead or… more
- Boehringer Ingelheim (Ridgefield, CT)
- … complexity and/or business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and ... lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible...relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director, acts as liaison to… more
- BeiGene (Harrisburg, PA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Sr . Scientist, Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls ( CMC ... Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …portfolios assigned. **A typical day may include the following:** + Responsible for CMC product development activities from a regulatory standpoint during early ... submissions and post market requirements for Cell and Gene therapies + Provide regulatory interpretation, position and strategy for global CMC /CP regulatory … more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... The PDS&T Parenterals/Eye Care group is seeking a motivated Senior Scientist as a CMC drug product...+ Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence… more