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Experience in roles such as Policy Analyst, Policy Associate, Communications Analyst, Communications Associate, Regulatory Affairs Analyst, Regulatory Affairs Associate, Regulatory Analyst, Regulatory Associate.
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Director, Regulatory Affairs CMC. 10+ 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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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ. The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
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You will be a part of the CCIA Clinical Affairs team and report to the Senior Director Clinical Affairs responsible for managing the CCIA portfolio for the Clinical Affairs department.
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote.
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Primary responsibilities are to support Shell Energy's wholesale/retail trading/origination businesses and Shell Renewable and Energy Solutions related businesses through external advocacy for competitive markets, communicating regulatory changes and impacts of regulatory changes to commercial teams, conducting due diligence on deals to facilitate commercial transactions within existing regulations and managing compliance obligations and reporting in the ERCOT Region.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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regulatory affairs jobs Title: sr director Company: Csl Behring
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