- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage ... Experts. **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs ( CMC ) is responsible for… 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
- 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
- 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)
- …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
- 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
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Actalent (Cambridge, MA)
- … regulatory vendors. The ideal candidate will have a strong background in regulatory affairs and experience with IND and BLA submissions. Responsibilities + ... Submissions Specialist to manage submission-related activities, working closely with regulatory and CMC leads to create content...+ Serve as the point of contact and alliance manager for selected regulatory vendors, ensuring timely… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67683 Date: Oct 16, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Thank you for your interest in our Sr ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more