- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Manager , Regulatory CMC Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... immunological diseases. Position Summary: Vera is seeking a Senior Manager , Regulatory CMC to join...requirements. * Represent Regulatory Affairs (Clinical and CMC ) on cross-functional project teams. * Evaluate… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… 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 ... and Cell Therapies and/or other biologics. **Responsibilities** + Provides CMC regulatory support and guidance to project teams for clinical development and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as GRA CMC Product Lead. Represents and contributes to Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical development ... CMC member, ensures and / or enhances regulatory compliance. + Ensures project team colleagues,...according to agreed business priorities. + As a line manager role, provides project and administrative oversight… more
- Gilead Sciences, Inc. (Foster City, CA)
- …implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in initiatives ... in the regulatory landscape. Analyze evolving legislation, regulatory guidance and provide analysis to the project...Master's Degree with 3+ years of industry experience in CMC regulatory affairs; or Bachelor's Degree with… more
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate ... and regulatory requirements. + Proven track record in supporting CMC programs from development to commercialization. + Experience in biotech, pharmaceutical, or… 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 ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge… more
- West Pharmaceutical Services (Exton, PA)
- …latest guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs ... Sr. Specialist, Regulatory Project Management (Evergreen Posting) Requisition...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will be responsible for the planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM ... Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and...CMC development and commercial teams, GMP environment and regulatory affairs + Prior experience in project … more
- United Therapeutics (Silver Spring, MD)
- …Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial ... and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ...on the development of regulatory strategy, providing regulatory advice and oversight to project teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about us:** At ... + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation...representative or team lead). + Represent functional area on CMC project teams by communicating activities from… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …At Takeda, we empower you to shape your future. Join us as a Manager of Statistics at our Cambridge, MA office, where every individual's contribution is valued. ... role, you'll play a key part in our bold and inspiring mission. As Manager of Statistics, you will provide statistical leadership in the design, analysis, and… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Provide proactive support and technical assistance during preparation and review of regulatory documents + As assigned, participate in project teams + Assist ... Works with manager to compose letters incorporating NN position on external regulatory initiatives + Works with Group Manager to maintain surveillance of … more
- Integra LifeSciences (Plainsboro, NJ)
- …are challenging what's possible and making headway to help improve outcomes. The **Senior Project Manager ** is a key member of the value stream leadership team ... for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is responsible for leading cross-functional teams… more
- System One (Florham Park, NJ)
- …help implement Regulatory Operations' initiatives by attending and participating in Project Teams if deemed appropriate by manager . + Maintain knowledge of ... process improvements. In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills and… more
- Novo Nordisk (Boulder, CO)
- …and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...and prioritize) + Proficient in MS Word, Excel, MS Project & PowerPoint + Understanding of national and international… more
- Vera Therapeutics (Brisbane, CA)
- …Associate Director, Project Management. The ideal candidate will work with the Regulatory team to develop project plans and to ensure that these are ... and timelines with other functional areas including Clinical, Clinical Operations, and CMC . * Provide project management support for briefing documents and… more
- Merck (North Wales, PA)
- **Job Description** **Job Description:** The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the ... organization of our company. ** ** **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of Early Drug Development… more
- Johns Hopkins University (Baltimore, MD)
- …Johns Hopkins based research-related staff, including research coordinators, assistants, regulatory specialists, etc. is required. Training and oversight of ... international study site team members remotely and onsite to meet project milestones and ongoing deadlines; international travel to sites to conduct site assessment,… more
- BeiGene (San Mateo, CA)
- …for regulatory technology and submissions (eg, eCTD, IDMP, SPOR/DADI, PQ- CMC , SPL) and coordinate impact assessment on systems and relevant data elements ... RIM function at BeiGene drives strategies, implementation and management of regulatory system processes and information, by collaborating with cross functional teams… more
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