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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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And respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology. Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission.
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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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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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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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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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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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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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regulatory job Title: sr regulatory affairs associate in Watertown, MA
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