- 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 ... for patients suffering from immunological diseases. Position Summary: Vera is seeking a Senior Manager , Regulatory CMC to join an experienced, fast-paced… 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...needed throughout product life cycle. Escalate critical issues to senior management. + Lead or contribute to development of… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for… 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 ... implements effective development plans. As part of the GRA CMC team, you will report to the Senior...Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… 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 about ... and regulatory requirements. + Proven track record in supporting CMC programs from development to commercialization. + Experience in biotech, pharmaceutical, or… more
- Atlantic Health System (Pompton Plains, NJ)
- …data to measure the effectiveness of patient care. 4. Works with senior leadership, interdisciplinary teams and other stakeholders in order to develop, implement ... assistance from other health care professionals within the system and from regulatory agencies. 8. Protects patients and employees by developing and interpreting… more
- United Therapeutics (Silver Spring, MD)
- …cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ... Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- System One (Florham Park, NJ)
- Senior Regulatory Operations Associate Contractor (Publishing) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) ... Senior Regulatory Operations Associate Contractor The ...to provide input on submission timelines in collaboration with Manager , Regulatory Operations. + Ensure consistency across… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- QC Stability, Senior Manager - Monroe, NC Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... oversight, and ensure compliance with internal procedures, industry regulations and regulatory guidance documents. Write, execute, and manage the stability program… more
- Bristol Myers Squibb (Summit, NJ)
- …this is not a laboratory-based position. **Key Responsibilities** + Work with Engagement Manager and team to deliver Regulatory documents and / or ... in support of CMC submissions + Attend and participate in various Regulatory and matrix team meetings, as needed and applicable + Manage and prioritize multiple… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing… more
- Novo Nordisk (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel ... to compose letters incorporating NN position on external regulatory initiatives + Works with Group Manager ...and assignments + Participates in department forum meetings eg CMC , PRB, and ensures that proper minutes from these… more
- Integra LifeSciences (Plainsboro, NJ)
- …of us 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 stream manufacturing manager , this position is… more
- Takeda Pharmaceuticals (Boston, MA)
- …with significant experience within related functions (eg Marketing, Clinical Operations, Regulatory , Manufacturing, CMC , Clinical Science) + Minimum of 3 ... Team (GPT) strategy into an efficiently executable plan working closely with a senior GPM; predicting and planning solutions to achieve program goals and objectives;… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Senior Manager , Manufacturing is responsible for plant production activities for ... CMC (Collagen Manufacturing Center). This includes assigning and monitoring...minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned… more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible… more