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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Project may include local roadway/highway design, hydraulic/hydrologic analysis, storm/sanitary sewer design, site grading, preparation of stormwater pollution prevention plans including design of post-construction stormwater management and sediment and erosion controls, utility design, permitting, and coordinating with regulatory agencies and other design disciplines.
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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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Knowledge of: wastewater treatment plant operating procedures*; equipment utilized in treatment processes; regulatory standards*; custodial methods; hazardous chemicals; safety practices and procedures; laboratory testing methods and procedures*; laboratory equipment and supplies.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Knowledge of relevant regulatory requirements, preferably relating to regulated financial institutions and / or consumer products and AML/ Anti-Corruption/BSA. We create and maintain the overall risk management framework while ensuring legal and regulatory compliance.
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Experience and proficiency in managing the work products needed to support regulatory permit applications, CEQA documents, and environmental due diligence investigations (e.g., wetland delineations, rare plant surveys, habitat assessments, biological resources technical reports.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Directing and providing guidance for all aspects of regulatory examinations by the FRB, DFS, SEC, CFTC, FINRA, NFA, state regulators and exchanges. The Compliance Regulatory and Assurance (CPL RA) team is a recently established “Center of Excellence” within the CACIB Compliance Function reporting directly to the Chief Compliance Officer (CCO.
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Regulatory Affairs: Prepare and review regulatory submissions related to DMPK, including INDs and NDAs. Interact with regulatory agencies as needed to address DMPK-related inquiries and ensure compliance.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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More details on our benefits can be found on our website at to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
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Manage the bioanalytical assay transfer/validation, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. + Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA.
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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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Firm Type: Law Firm, Experience: 15 Years, San Francisco office of our client seeks a deputy general counsel healthcare-commercial and regulatory with 15+ years of relevant legal experience, preferably in-house, advising healthcare, healthcare technology, or employee benefits companies.
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regulatory job Company: Metroplus Health Plan
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