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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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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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Reporting to the Regulatory Affairs Research Teams 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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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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Join Our Crew Senior Manager, Technical Writer, Regulatory Affairs (Remote) Philadelphia, PA. 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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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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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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Leads the Early Development Pharmaceuticals GRA CMC TAK-279 regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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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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Knowledge and experience in the areas of pharmacokinetics, drug metabolism, precision medicine and/or regulatory affairs. Familiar with regulatory agencies documentations such as new drug application (NDA) from organizations including but not limited to FDA, EMA, and PMDA.
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Collaborates with study team members (including Clinical Operations, Drug Safety, Regulatory Affairs, Precision Medicine, Project Management) to ensure that key milestones are met on time and with high quality.
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Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.
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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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Legislative Initiatives: Oversee the department’s efforts to understand and provide guidance on matters coming before City Council that have an impact on the Streets Department’s operations; supervises the Department’s Legislative and Regulatory Affairs Manager who coordinates such matters on a day-to-day basis.
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regulatory affairs jobs in Cherry Hill, NJ
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