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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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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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BDP International, a member of the PSA Group, is a leading provider of global, integrated supply chain, transportation and logistics solutions.
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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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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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The NCI/NCTN Senior Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation.
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Depth of knowledge and practical use with regulatory guidelines including but not limited to CFPB, FDIC, FRB, OCC, and NCUA compliance examination procedures. As a Regulatory Compliance and Operational Risk Senior Manager, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Risk Advisory Practice – all with the resources, environment, and support to help you excel.
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Compliance, Operational Risk and/or Regulatory Compliance or related consulting experience. You'll collaborate with teams to provide comprehensive compliance optimization strategies, to help clients remediate regulatory gaps, streamline operations and limit risk exposure.
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Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities. Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval, and implementation of promotional materials and other related activities with an increased level of independence.
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Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolution, and assist with strategic forward planning.
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This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting materials to the client (both electronically or in hard copy as determined by the clients' specifications), and tracking the progress of each project through the stages of MLR review.
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Deep competency in developing optimal regulatory strategy globally and understanding of regulatory requirements throughout the development spectrum (preclinical to post-marketing). M.D. or PhD with 7-12 years relevant drug development experience required preferably with 5 years in Regulatory.
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Assists the Director of Regulatory Compliance with property level compliance with the Bank Secrecy Act (BSA) and FinCEN regulations and the Company’s BSA Title 31 anti-money laundering policy, to ensure the property is in compliance with regulations pertaining to money laundering.
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The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters.
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Senior leader to advance BCBSA's legislative and regulatory policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program, impacting the tens of millions of Americans we cover, serve, and support in these programs.
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Title: regulatory Company: Impact Legal Resources in Bryn Mawr, PA
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