- 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
- 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
- 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. (Santa Monica, CA)
- …complex regulatory submissions which require interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products ... regulatory skills and knowledge, under guidance of immediate manager + May initiate or contribute to local process...contribute to local process improvements as they relate to Regulatory Affairs CMC function +… 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
- AbbVie (Mettawa, IL)
- …timely issues. + Develops and implements policies and procedures within the regulatory affairs department. + Analyzes legislation, regulation, and guidance and ... input into the preparation and maintenance of chemistry, manufacturing, and controls ( CMC ) device sections of regulatory submissions, responses to Agency… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67683 Date: Dec 13, 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …cell therapies, and other drug modalities. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... you to shape your future. Join us as a Manager of Statistics at our Cambridge, MA office, where...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- Sumitomo Pharma (Columbus, OH)
- …changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with ... global contract testing laboratories in partnership with the Company's CMC Team. The Senior Manager also participates...pharmaceutical products or clinical trial materials. Authors and/or reviews regulatory IND, IMPD, CTD and BLA/NDA CMC … 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
- 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
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