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CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred) 2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required.
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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.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As an integral member of Pharmacy Services, the IDS/Pharmacy Regulatory Coordinator's role also includes assuring accurate record keeping, filling, compounding and delivering of investigational drug products to study coordinators, study nurses and patients.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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Providing comprehensive and high-quality legal support in the areas of sales, marketing, promotional/medical/patient materials, patient access/support/reimbursement, government contracts and pricing, managed care, fraud & abuse, and regulatory and legal compliance with federal and state statutes, FCPA, rules and regulations, privacy, safety/product liability law, and other laws, regulations and Company policies and procedures.
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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Design project plans and assist with the development of associated technical reports, cost estimates, and specifications for water / wastewater treatment & conveyance projects; this will include coordination with regulatory agencies for associated permitting.
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Expertise in stormwater management design, hydrologic/hydraulic analysis and design, and SWPPP preparation; Provide expertise in hydrologic/hydraulic analysis and design including SWPPP preparation and water quality compliance.
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5 years working in risk and regulatory compliance within the banking, capital markets and/or insurance industries (including thorough knowledge of the Basel Accord, Dodd Frank, FBO, FINRA, SEC, FinCEN, OCC, FDIC, CCAR, etc.
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Audit operational areas and delegated vendors for compliance and ensure Jefferson Health Plans (JHP) is meeting applicable federal and state laws and regulations, and contractual requirements as set forth by all regulatory entities including but not limited to Pennsylvania State regulatory agencies (DHS, DOH and PID) and Centers for Medicare and Medicaid (CMS.
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Communicate with class, USCG, FDA and any other required regulatory agency to resolve any regulatory or inspection issues raised during construction of the vessel. Maintain working knowledge and monitor development of classification and regulatory rules and requirements.
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About the Position Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
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Department members continually work with senior members of Customer Operations, Regulatory and External Affairs, Transmission Operations, Finance, Accounting and outside consultants in performing daily responsibilities and supporting strategic initiatives.
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Develops/Reviews Stormwater Management Reports and Stormwater Pollution Prevention Plans (SWPPP) to support regulatory permits; Conversant with regulatory codes, design codes and standards, best management practices, permit requirements and construction practices.
$93,400 - $155,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experienced in the set up and maintenance Trial Master File and thorough understanding of relevant regulatory requirements as they relate to both the TMF and clinical study conduct. Assist with the management and maintenance of the electronic Trial Master File (eTMF) system and in supporting or leading systems integration efforts with systems that interface with the eTMF, for example, regulatory (e.g., RIM), and quality systems (e.g., QMS.
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swppp regulatory jobs in Philadelphia, PA
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