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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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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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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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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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Providing leadership in developing and presenting approved positions of members of the solid waste management industry on public policy and regulatory issues, The Governmental Affairs Director reports directly to the Executive Director/CEO and works closely with the Steering Committee, Board of Directors, and is the direct staff liaison to the Government Affairs Committee.
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Facilitate regulatory intelligence review meetings and/or learning series sessions.
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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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Join Arkema in Wauwatosa, USA, as a Product Stewardship and Regulatory Affairs Specialist. If you are a driven individual with an interest in regulatory affairs and product stewardship, apply now.
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The candidate should have over 12 years of experience in pharmaceutical/biotech drug development, including more than 4 years in global CMC regulatory affairs, with expertise in PDM development for NCEs/small molecules.
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They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Minimum of 5+ years of experience in a Regulatory Affairs for medical devices and drug-device combination products.
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A minimum of 6-10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. Maintain up-to-date knowledge of current and future product stewardship, chemical regulatory compliance, and sustainability issues through membership in trade associations and external committees, regular review of relevant publications and subscription services, and interactions with external experts and advisors.
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regulatory affairs jobs Title: review Company: Grindwerk in WY, Nevada
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