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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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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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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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Support authoring and manage document workflows for planned major submissions including health authority meeting packages, original INDs/CTAs, and protocol amendments:· Lead interactions with external regulatory submissions vendor· Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.
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EducationBachelors Degree (Required)Masters Degree (Preferred)Combination of relevant education and experience may be considered in lieu of degree.
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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 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 regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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The Director of Academic Affairs would have several direct reports and oversee several academic-facing functions, such as our Research Grant Administration Officer, our institutional Compliance Department/resources, and the Scientific Grant Writer.
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Support coordination and implementation of global HTA strategies, including dossier development and submissions, in collaboration with Medical & Scientific Affairs and Market Access colleagues.
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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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The FRM will need to coordinate cross functionally within Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, and Specialty Pharmacy Account Management.
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Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions? The Senior Manager/Director of Policy and Regulatory Affairs will play a pivotal role in shaping and advancing our client's strategic initiatives across PJM and regulatory landscapes.
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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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Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network. Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network.
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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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regulatory affairs jobs Title: intern Company: Alcorn State University in Cherry Hill, NJ
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