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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: 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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Penn Medicine's Abramson Cancer Center (ACC) seeks a full-time Director of Regulatory Affairs ("Director") to oversee a large, expansive portfolio of oncology research across Penn Medicine's multi-hospital health system.
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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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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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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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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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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 teams success in meeting goals/objectives.
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The attorney will work on a wide range of transactional and compliance matters handled by the Airport Division, including negotiating and drafting of contracts and advising the airport's senior executives on legal and regulatory matters for the City to operate and develop its two airports.
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Collaborates with Student Affairs and Global Centers to support and improve student and exchange visitor services/initiatives. Reporting to the Senior Associate Provost for Academic Enterprise Initiatives, the Executive Director for International Services will successfully lead employee visa programs and export compliance and will, as needed, provide support to student and exchange visitor services.
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In coordination with the commercial strategy team, serving as day-to-day lead and strategic legal business partner to the commercial, medical and regulatory affairs teams, as well as patient advocacy/support teams, in connection with the Company's efforts to commercialize products.
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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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This position reports to the provost/vice president for academic affairs. REPORTS TO: Vice President for Academic Affairs. The dean serves as the Brind School's chief academic, creative, and administrative officer, and producing artistic director.
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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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regulatory affairs jobs Title: sr director Company: Csl Behring in Philadelphia, PA
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