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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Our department works closely with Analytical Development, Operations, Regulatory Affairs, and Quality control to formulate and manufacture innovative ocular formulations. Knowledge of current regulatory guidance and experience in managing IND/IMPD filing.
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Manage CRO interactions for timely DMPK study execution; support regulatory document preparation and presentation/publication strategies. Strong understanding of PK/ADME assays, methods, and models, as well as expertise in managing CROs and knowledge of regulatory guidance’s.
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Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs. Working knowledge of quality systems and regulatory requirements with prior experience in preparing and defending regulatory filings.
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Works closely with outside regulatory agencies, parole, probation, families, and other collateral contacts to ensure excellent communication and teamwork between Rushford and our treatment partners.
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You will be the in-house expert of all OSHA, EPA, DOT, NIOSH, NFPA and other regulatory issues relative to the facility and grounds. Competitive salary & bonus potential Comprehensive health benefits Generous PTO & paid holidays 401(k) with match & profit sharing Career advancement opportunities Family values culture & respectful work environmentJob DetailsThe Facility (EHS) Specialist is responsible for ensuring compliance with all OSHA and EPA programs.
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This role will provide short- and long-term strategic leadership of safety surveillance for Dyne's clinical development programs, including resource planning and long-range capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management.
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Maintain awareness of the current state of the field (literature, regulatory expectations, and competitive surveillance), and contribute to the broader cell and gene therapy industry and academic ecosystem through publications and conference presentations.
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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Direct: Union and/or non-union warehouse on-floor associates (Loaders, Selectors, Receivers, Forklift drivers, etc.
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Acts as a liaison between contractor and the VAMC.Participates in the ongoing Performance Improvement Program between STGi and VAMC.Complies with all federal, state, local, Joint Commission, Occupational Safety and Health Administration (OSHA), Veteran Affairs, STG and subcontractor safety and operational regulations, directives and standards.
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Comply with all federal, state, local, Joint Commission Occupational Safety and Health Administration (OSHA), Veteran Affairs, Subcontractor safety and operational regulations, directives and standards.
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Collaborate with cross-functional teams, including translational research, Clin ops, regulatory affairs, Medical Writers etc to ensure alignment of clinical strategies and efficient communication.
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Perform FAI/CVI (Annual) inspections on all fleet vehicles including tractors, trailers, converter dollies, light-duty vehicles, and any other company-owned equipment in accordance with all federal, state, and local legal and regulatory agencies.
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STEP THREE: Connect with a Sysco talent specialist to discuss the available role (we'll contact you at the number provided) Perform quality preventive maintenance inspections per company methods on all fleet vehicles including tractors, trailers, converter dollies, lift gates, light-duty vehicles, and any other company-owned equipment.
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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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regulatory affairs jobs Title: director in Watertown, Beech-grove, Indiana
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