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Conduct training sessions in CMC regulatory affairs or pharmaceutical development. Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files.
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Coordinates activities associated with the development, negotiation, and execution of contracts, change orders, CDAs, and consulting agreements for services required by internal stakeholders (Clinical Operations, Medical, Medical Writing, Clinical Supplies, Clinical Development, Data Management and Statistics, CMC, Finance, Legal, Regulatory Affairs, etc.
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Industry specific certification related to anti-money laundering, regulatory compliance, and regulatory affairs. Acts as support for the Safety Specialist in their absence.
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FDA is actively seeking an on-site Record Management/Administrative Support Specialist to provide administrative services to support the initiative of electronic submission, notification, and retention of Office of Regulatory Affairs (ORA) analytical worksheet records and perform other document inventory and management duties and basic administrative support to the Office of Regulatory Affairs, Office of Regulatory Science.
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Regulatory Affairs Operations Specialist I. Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities.
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The Client Development Specialist supports the Regulatory and Government Affairs (RGA) Department, including revenue-generating and general marketing and practice visibility opportunities.
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We are currently seeking a Regulatory Specialist who is responsible for providing support for all internal/company and external/client regulatory-related activities. Minimum of 4-6 years of experience in regulatory affairs, QA, or equivalent.
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Assist Customer Service, Technical Support, Regulatory Affairs, and Analytical Services in addressing customer inquiries and concerns. Job Title: QA Specialist. Perform all job duties within ISO standards, regulatory or statutory requirements.
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As a Regulatory Affairs Specialist at Augmentjobs, you will be a key player in ensuring that our products and services comply with all relevant regulations and standards. Job Title: Regulatory Affairs Specialist.
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National Association of Medical Staff Services - Certified Provider Credential Specialist (CPCS) preferred. Provides support to the medical staff officers and chairmen particularly the Chairman of the Credentials Committee and Vice President of Medical Affairs and contributes to the maintenance of an accurate and complete medical staff credentials file.
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Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Support the preparation of dossiers and submission packages for regulatory agencies, including IVDR Technical Dossiers for CE Mark approval.
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Responsible for developing a strong understanding of the services provided by the RGA Practice and of the clients and industries these groups operate within. Provides support to the Digital and Communication teams to promote firm thought leadership, including monitoring, processing and distributing client alerts and blogs.
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Senior Multilateral Analyst Regional Analyst Specialist Multilateral Affairs Manager Multilateral Relations Advisor Regional Diplomatic Analyst Multilateral analysis Regional diplomacy Policy evaluation International relations Strategic planning Legal Disclaimer: Cherokee Federal is an equal opportunity employer.
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This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs.
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Job Title: Regulatory Affairs US Biologicals labeling specialist. Support regulatory filing submissions with the USDA for both domestic and international product packaging.
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