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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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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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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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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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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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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 Scientific Affairs Manager is a key member of the content development team who utilizes their combined skills as a scientific medical writer, educational design innovator, and grant development specialist to conduct a turnkey process that includes educational grant development, followed by content development for awarded grants.
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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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Essential Job Functions:Provides strategic advice on complex reporting and technological issues raised by the MRTS business units, Regulatory Services Management (“RSM”) team, Regulatory Operations teams, and other FINRA customers, as applicable.
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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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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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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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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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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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regulatory affairs jobs Title: regulatory affairs assistant Company: Kelly Services in Cherry Hill, NJ
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