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We are seeking a global Executive Director, Regulatory Affairs, Gene Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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The Director must understand the entire preclinical and early clinical product development pipeline including product optimization, preclinical scale-up, and manufacture and toxicology, regulatory affairs, and early human clinical trials.
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Familiarity with FDA regulatory process. a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or.
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The Montgomery County Department of Housing and Community Affairs (DHCA) is currently seeking to fill two Housing Code Inspector positions. Montgomery County Government is an equal opportunity employer, committed to workforce diversity.
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Examples may include use of regulatory guides, industry codes, and standards, Federal and state emergency preparedness and incident response programs, and applicable FEMA or EPA regulations/guidance.
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Participate in community affairs and maintain positive public image for the property and HEI Hotels and Resorts. For your physical and mental wellness we offer competitive Medical and Dental programs through Anthem Blue Cross Blue Shield as well as Vision insurance programs.
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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Experience in investigational drug management, clinical research, protocol development and conduct, regulatory affairs (e.g., GMP manufacturing, IND filing, adverse events) and/or allergy or infectious diseases practice is required.
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The Technical Expert is responsible for understanding the regulatory and policy landscape for genetic biocontrol approaches to control malaria and other vector-borne diseases; planning and implementing a portfolio of activities to provide technical information and advice on regulation and policy to stakeholders; and collaborating with partners to build regulatory and policy capacity, particularly through online and in-person trainings.
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As a full-service environmental consulting practice, services include impact assessment and planning, regulatory compliance and permitting, wetland and floodplain analysis, waterbody and water quality assessment, air quality permitting and management, environmental remediation, site due diligence, environmental noise assessment, pollution prevention planning, and climate action solutions.
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He/she works closely with Director, Clinical Supplies, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for clinical trials.
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JOB SUMMARY*This is a hybrid role located in our Bethesda, MD HeadquartersThe Social Impact, Multicultural Affairs & Business Councils team is part of the Global Communications and Public Affairs function at Marriott International and is responsible for social responsibility, volunteerism, external stakeholder engagement and a portfolio of initiatives and partnerships which aim to connect our business with communities to drive positive social outcomes and business value.
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He/she works closely with Director, Clinical Pharmacy, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for all clinical trials.
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Supports Customer Due Diligence processes, ensuring timely completion and accuracy of policy and regulatory requirements related to Anti-Money Laundering (AML), money services businesses, other high-risk indicators or industries, and related KYC activities.
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The Regulatory Compliance Coordinator (RCC) shall have detailed knowledge of federal regulations and policies related to use of animals in research. OVERVIEW: Responsibilities of this position are that of a Regulatory Compliance Coordinator for the Animal Care Project.
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regulatory affairs jobs Title: regulatory assistant Company: Jobget in Rockville, MD
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