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Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies. Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRCMC regulatory scientists.
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The Senior Formulation Chemist plays a crucial role in propelling the organization forward through strategic product innovation, enhancement, and adherence to regulatory standards. The Senior Formulation Chemist is a key driver of the organization’s growth, leveraging their expertise to set new benchmarks in product development and quality assurance.
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Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Responsibilities:- Ensure compliance with regulatory requirements for working with animals in biomedical research, including the Animal Welfare Act & Regulations, the Guide for the Care and Use of Laboratory Animals, local policies, and other applicable regulations.
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Our research programs encompass a broad range of biomedical research activities and areas of study, focusing on various fields such as cardiovascular disease, alcoholism, hematopoietic cancer, behavioral research, aging, and gene therapy.
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Serve on department, campus, and university committees as assigned IACUC, IBC). Review IACUC and IBC protocols and provide post-approval monitoring. Position Summary Clinical Veterinarian The Laboratory Animal Resource Center (LARC) at a prestigious institution is seeking a customer service-oriented individual to join our team as a clinical laboratory animal veterinarian and Assistant Director.
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Serve on department, campus, and university committees as assigned (e.g., IACUC, IBC). Stay updated on issues in laboratory animal medicine, animal care, and science. However, qualified individuals with documented past academic rank advancement may qualify for the associate scientist faculty rank.
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At LARC, we provide comprehensive care and housing for multiple species of laboratory animals, with a primary emphasis on swine, dogs, rabbits, frogs, and rodents. Communicate with internal and external customers regarding significant changes in animal health, husbandry/environment, and study conduct.
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Develops and maintains operating procedures and guidelines for animal care staff and facility users; ensures compliance per IACUC and other regulatory agencies; develops and enforces procedures to ensure current and continued compliance with regulations; maintains compliance-related records, information, and/or reports.
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Assists in Corporate Security and Regulatory Affairs (CSRA) training program development and training presentations related to DCP, OMP and general pharmacy operations. What you will be doingUnder general direction of the Senior Director, Diversion Control and Federal Investigations, and working closely with the Director of the Diversion Control, responsible for supporting all pharmacy inspections, pharmacy data analysis, and liaison with state and federal pharmacy regulatory authorities on matters related to Cencora's Diversion Control Program (DCP.
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Certified Dietary Manager (healthcare/dietary/dietitian) Job ResponsibilitiesSpecific duties for this Certified Dietary Manager position include:The Dining Services Director is responsible for the management of all dining services and personnel to ensure that nourishing, palatable, and well-balanced meals are prepared and served to meet the daily nutritional and special dining needs of each resident consistent with accepted nutritional standards and regulatory requirements.
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Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE, Series 7 Top Off and Series 66 licenses, fully paid for and sponsored by Fidelity.
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Experience using eCTD compliant publishing system (eCTDXpress or Veeva based platforms)Three years of regulatory operations experience within a regulated environment with experience and knowledge in formatting and publishing medium/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical.
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Willingly assists as needed in all peri-anesthesia settings including the preoperative area, PACU, and the Endoscopy PACU. · Maintains the principles of confidentiality and HIPPA. Understands the legal/regulatory requirements related to the release of information.
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Maintain a safe work environment and wear appropriate personal protective equipmentRequirements:Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements.
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cmc regulatory jobs in Indianapolis, Lexington, Massachusetts
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