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Senior Regulatory Affairs Specialist. Manage preparation of regulatory documentation to facilitate the commercialization of new products in the US and internationally. Maintain dashboard for regulatory approvals for international country license / registration renewals.
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Environmental Permitting: Assist clients in navigating the regulatory permitting process, including obtaining permits for activities such as air emissions, wastewater discharge, wetland impact, and hazardous waste management.
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A career in Treasury Advisory, within Risk & Regulatory Advisory, will allow you to advise financial institutions on developing strategies to optimize financial performance and risk management across financial risks, including liquidity risk, market risk, counterparty credit risk and interest rate risk.
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As a key member of the Quality Assurance and Regulatory Compliance team, this role will support the regulatory needs of Dana-Farber's new inpatient cancer hospital and new collaboration with Beth Israel Deaconess Medical Center as that work ramps up.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post market surveillance. Demonstrated understanding and experience of working in the medical device industry, familiarity with product development procedures, design control documentation and FMEA, quality assurance and regulatory standards.
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In collaboration with the Associate Chief Nurse, the Nursing Director plans, organizes, implements and oversees clinical and program development in the assigned area(s) to contribute to meeting the mission and goals of Brigham & Women’s Faulkner Hospital as well as the regulatory requirements of the JCAHO and other applicable federal, state and local regulatory or accrediting agencies.
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Preferred] Experience in Financial Services/Security Industry and working with regulatory organizations such as: Securities and Exchange Commission (SEC), Commodity Futures Trading Commission (CFTC), Financial Industry Regulatory Authority (FINRA), Federal Reserve.
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As the Senior Manager/Associate Director ofRegulatory Strategy, you will play a critical role in driving the developmentand execution of regulatory strategies for our rare disease therapeuticprograms.
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Familiarity with Applied Behavior Analysis and competency in the implementation of fundamental procedures as described in Epic’s training protocols and any regulatory or funder requirements (e.g., registered behavior technician training.
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The person will work directly with stakeholders across – ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. 6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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Knowledge of CFTC & NFA swap regulations is preferred to enhance the compliance program and assist the swap dealer and the Swap Dealer Chief Compliance Officers (CCO) to satisfy their regulatory obligations.
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Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.
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regulatory job Title: sr regulatory affairs associate in Wakefield, MA
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