- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to ... Support CMC development activities from a regulatory standpoint during early phase, development, submissions and post market requirements for gene therapies. **A… 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 ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… 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 CTD CMC sections for assigned projects to ensure on-time and high-quality global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in initiatives internal to ... Qualifications** + Master's Degree with 3+ years of industry experience in CMC regulatory affairs ; or Bachelor's Degree with 5+ years of pharmaceutical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate, CMC Regulatory Affairs - Biologics** Gilead Sciences is seeking ... role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job...the product license. + Develop and maintain knowledge of regulatory requirements independently and with line manager .… more
- Takeda Pharmaceuticals (Lexington, MA)
- … where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products ... Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...according to agreed business priorities. + As a line manager role, provides project and administrative oversight to support… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as a Sr associate, Global Regulatory Affairs CMC Submission Management where you will support ... manage multiple and simultaneous projects. As part of the Regulatory Affairs CMC team, you...CMC team, you will report to the Senior Manager GRA CMC and work with the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry… more
