- 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 (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
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- AbbVie (North Chicago, IL)
- …. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… 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
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… 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
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more