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The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office.
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The Department of Pharmacology and Toxicology within Developmental Sciences is seeking an experienced regulatory/project toxicologist and strategic leader to develop and lead the execution of nonclinical safety strategy for gene therapy programs at Spark.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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Responsibilities: The following regulatory duties will be performed under general supervision by the Assistant Director of Regulatory Affairs and/or Clinical Trials Manager-Regulatory Affairs: 1.
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KNOWLEDGE, SKILLS, and ABILITIES Bachelors in any of the following degrees from an accredited university/college: Regulatory Science, Regulatory Compliance, Regulatory Affairs, Environmental Science, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
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The Senior Accountant – Regulatory Reporting and Compliance is primarily responsible for preparing and filing required reports to the Federal Energy Regulatory Commission, Railroad Commission of Texas, and to other federal and state agencies.
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Track animal care and sustainability developments in legislative/regulatory affairs across species (cage-free, animal medication/housing, etc.) Work alongside Coca-Cola corporate teams to identify issues, legislative, regulatory, and lobbying opportunities.
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Work in a dynamic, matrixed environment by collaborating closely with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and project management teams, while following GCP and industry best practices.
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Senior Manager, CMC Vaccines Mature Products (Global Regulatory Affairs) Lead CMC regulatory activities in the late development and/or lifecycle management of GSK products. Ensure all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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Learn more about Deloitte's FSI Risk, Data and Regulatory practice. Deloitte Risk and Financial Advisory Risk, Data and Regulatory Liquidity - Manager. Exposure to firm-wide governance frameworks for liquidity risks, including enhancements related to the changing regulatory environment and compliance with regulatory expectations.
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Demonstrate understanding of business processes, regulatory requirements, internal control risk management, process, data and technology controls and related standards and frameworks as related to financial institutions.
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Prior experience in compliance, product controllers, legal, regulatory, audit or risk management functions in the firm's various businesses, e.g., consumer banking, asset or wealth management and/or global banking and markets businesses.
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regulatory job Title: regulatory affairs specialist Company: Parexel
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