- 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
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... initiatives internal to RA CMC . + Represents CMC regulatory affairs on project...is flexible. Applicants may be considered for the Senior Manager or Associate Director level based on qualifications. This… 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
- Chiesi (Boston, MA)
- …Chiesi." **_Who we are looking for_** **Purpose** Currently seeking for a Regulatory Affairs (RA) Manager with strong CMC pre and post approval ... Manager , Regulatory Affairs Operations,... Manager , Regulatory Affairs Operations, Rare Diseases Date:...+ Execute preparation of timely responses to small molecule CMC regulatory questions in coordination with impacted… 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
- 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
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67683 Date: Jan 11, 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Knowledge of pharmaceutical industry and project management experience within Medical Affairs , Clinical Research, Regulatory , CMC , Marketing or other ... Experience managing program level budgets across multiple projects + Knowledge of regulatory and compliance guidelines governing medical affairs + Applied… 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