- 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
- 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
- System One (Florham Park, NJ)
- …+ Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance in a ... meetings to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across regulatory… 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 ... If so, be empowered to take charge of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here, everyone matters and you will be a… 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 (Lexington, MA)
- …with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC - regulatory Affairs , while serving as an important point ... in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs . + Experience managing technical capabilities in a global… 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
- United Therapeutics (Research Triangle Park, NC)
- …+ Collaborate with the Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, ... and other orphan diseases. **How you'll contribute** The Clinical Supply Chain Manager will manage assigned study supply, availability and delivery of Clinical Trial… more
- Vera Therapeutics (Brisbane, CA)
- …in collaboration with CMC Operations, Clinical Development, Clinical Operations, Regulatory Affairs , Nonclinical Development to ensure the clinical supply ... from immunological diseases. Position Summary: Reporting into the Senior Vice President, Regulatory and Quality, the Vice President, Quality will be responsible for… more
