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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. 15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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The Energy Manager's primary function will be to negotiate and manage electricity and natural gas contracts / agreements / programs for CMC facilities and to promote / support energy policy important to CMC before legislative bodies, regulatory authorities, utilities, and other external bodies.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Lead early and late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS/Labeling support.
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Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development.
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Understanding of CMC, QA, regulatory and clinical stages to guide preclinical activities setting up products for success at later stages. Individual will partner closely with the research team leads as well as other key stakeholders within Spark (regulatory, clinical, CMC, etc.
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Regulatory Affairs: Prepare and review regulatory submissions related to DMPK, including INDs and NDAs. Interact with regulatory agencies as needed to address DMPK-related inquiries and ensure compliance.
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Join Takeda as a Director, Global Regulatory Affairs CMC where you will oversee the development and execution of regulatory CMC development and registration strategies.
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regulatory affairs cmc jobs Title: director clinical in Troy, New York
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