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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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Effectively represent the Global Regulatory Affairs (GRA) function in senior-level interactions at internal governance technical review committees, key global health authority meetings, and external partners.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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The newly established Immune Health Initiative is hiring a full-time Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist to assist with departmental IRB maintenance and submissions and to perform routine internal study monitoring for all observational clinical research studies.
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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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Members of the Academic Affairs Manager (AAM) Team are the direct point of contact between the company and Colleges of Veterinary Medicine (CVMs) and Veterinary Technician Schools (VTS). The Academic Affairs Manager role is a field-based role within Hill's US Professional and Veterinary Affairs (PVA) Team, a team that serves as Hill's direct connection to the veterinary profession and the broader animal health industry.
$88,800 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The incumbent is responsible for analyzing PGW regulatory compliance in communications and actions from regulators and ensuring operating practices are in accordance with local, Commonwealth and federal regulations and requirements.
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Oversees regulatory compliance in partnership with the Chief Regulatory Affairs Officer, across all Temple campus', including but not limited to Temple University Hospital, Northeastern Campus, Episcopal Campus, Jeanes Campus and Temple outpatient clinics.
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How you will contribute: Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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Our department offers a wide range of programs, including a NASPAaccredited Master of Public Administration, an accelerated BA/MPA, an Executive MPA, an MS/PhD in Public Affairs, and a BA in Urban Studies and Community Development.
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2 Years experience in pharmaceutical development and/or manufacturing with CMC regulatory experience or related (e.g. CMC writer, lab experience). The Associate/Manager - CMC Regulatory is responsible for the preparation and delivery of high-quality CMC regulatory submissions.
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The Regulatory Law Unit's Airport Division is seeking a licensed Pennsylvania Attorney to fill an Assistant City Solicitor or Deputy City Solicitor position. The attorney will work on a wide range of transactional and compliance matters handled by the Airports Division, including negotiating and drafting of contracts and advising the airport staff on legal and regulatory matters, as necessary, for the City to operate and develop its two airports.
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Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops on-going professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Jazz Pharma in Philadelphia, PA
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