- 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 ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- 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 Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...risk and cost to the overall operation. Relationships The Associate , API Manufacturing reports to the Senior … more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure ... Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will… more
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …will assume a full-time employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** + ... countries worldwide, with headquarters in Foster City, California. **Sr. Associate , CMC Regulatory Affairs -...detail. Work is performed under limited direction of a senior Regulatory Affairs professional. **Minimum Qualifications:** +… more
- J&J Family of Companies (Harrisburg, PA)
- Associate Director, CMC Regulatory ... senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout ... 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs....leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior … more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Sr associate , Global Regulatory Affairs CMC Submission Management where you ... will support the execution of regulatory CMC investigational, registration and post-approval tasks...projects. As part of the Regulatory Affairs CMC team, you will report to the Senior… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… more
