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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Regulatory Affairs Specialist.
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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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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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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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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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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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Guides, directs and evaluates (1) Associate General Counsel, (3) Lease Administration Department (1) Senior Paralegals and, (2) Scientific & Regulatory Affairs Department. Provide guidance to Scientific and Regulatory Affairs on regulatory issues related to both product and procedures, including label safety, use of third party literature, and training documentation.
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OPPORTUNITY 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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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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Strong collaboration and partnership with cross functional colleagues globally (Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc) to ensure on-budget, timely, high quality delivery of the programs.
$187,000 - $242,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Evaluate capital projects to determine commercial and regulatory requirements related to the commercialization, construction, operation, maintenance, and abandonment natural gas pipeline and storage facilities.
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The Counsel position will be an integral part of the Regulatory, Operations, Government Affairs and Environmental team. The Counsel will assist the Deputy Chief Counsel and Principal Counsel on various transactional, operational and regulatory legal matters primarily for Disney Signature Experiences (with a focus on Disney Cruise Line) and also the Walt Disney World Resort.
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Represents Clinical Affairs line in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams as applicable.
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regulatory affairs jobs Title: associate deli service Company: Hannaford in Annandale, Virginia
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