- 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
- Regeneron Pharmaceuticals (Troy, NY)
- …+ 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
- System One (San Rafael, CA)
- Job Title: Senior Manager - CMC Regulatory Location: Hybrid - Local to San Rafael, CA Type: Contract Description: As a Senior Manager in the ... responsible/accountable for: RESPONSIBILITIES Planning, preparation and submission of global regulatory CMC -related content pertaining to clinical trial… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Fresenius Medical Center (Knoxville, TN)
- …+ Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support… more
- J&J Family of Companies (Spring House, PA)
- …or process excellence is preferred + Experience with clinical development and regulatory affairs is preferred + Project Management Professional (PMP) or ... & Johnson's Family of Companies, is recruiting for a Pharmaceutical Development Program Manager (PDPM). This position is to be located onsite/hybrid in Spring House,… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67683 Date: Feb 9, 2025 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
- Gilead Sciences, Inc. (Foster City, CA)
- …/pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs + Prior experience in project management required; PMP ... planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will...candidate will bring an understanding of drug development and regulatory processes, and the ability to assess and drive… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …including, but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA), Regulatory Affairs and ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply...any current or potential new CPOs. + Collaborates with Regulatory Affairs to provide all documents required… more
- Vera Therapeutics (Brisbane, CA)
- …and inventory management of clinical supplies. Working with third-party packaging suppliers, Regulatory Affairs , Quality Assurance, CMC , and the Clinical ... Title: Clinical Supply Chain Manager Location: Brisbane, California About Us: Vera Therapeutics...as part of a team with other members of CMC to ensure on-time delivery of IMP and adequate… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …emerging genetic medicine modalities in collaboration with the PK Subject Matter experts, Regulatory Affairs , and other relevant stakeholders. + Manage team of ... Regeneron is seeking a highly motivated ** Manager , Scientific Writing** to supervise regulatory ...Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content. **A Typical Day Looks… more
- J&J Family of Companies (Raritan, NJ)
- …in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs , CMC Regulatory Affairs , Product Artwork, and ... Johnson & Johnson is recruiting for a Manager , Global Labeling Operations to be located in...of Global Labeling Operations, including : + Provision of Regulatory guidance on the development of US packaging text… more