- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Novo Nordisk Inc. (Boulder, CO)
- …and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- Novo Nordisk Inc. (Boulder, CO)
- …API. Relationships The Technician II, API Manufacturing reports to the Senior Manager , API Manufacturing. Essential Functions Provides support for ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- Novo Nordisk Inc. (Boulder, CO)
- …the overall operation. Relationships The Associate, API Manufacturing reports to the Senior Manager , API Manufacturing. Essential Functions Responsible for the ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- BeiGene (San Mateo, CA)
- …aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop ... and implement small molecule regulatory CMC strategies as well as author...needed throughout product life cycle. Escalate critical issues to senior management. + Lead or contribute to development of… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in initiatives ... their aspirations. Join Gilead and help create possible, together. **Job Description** ** Sr Associate, Regulatory Affairs, CMC ** **Foster City, California**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Sr . Associate, CMC Regulatory Affairs - Biologics** Gilead Sciences ... the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** +...the product license. + Develop and maintain knowledge of regulatory requirements independently and with line manager .… more
- Takeda Pharmaceuticals (Boston, MA)
- …projects. As part of the Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC and work with the GRA CMC organization. **How ... bring life-changing therapies to patients worldwide. Join Takeda as a Sr associate, Global Regulatory Affairs CMC Submission Management where you will… more
