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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.
RemoteExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Regulatory Affairs, CMC, IND, IMPD/CTA, NDA, MAA, GMP. Director, Regulatory Affairs CMC. Lead the preparation and maintenance of the CMC / quality sections for regulatory submission, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
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The candidate will lead and manage FDA CBER IND & IDE application preparation and submission; IND & IDE maintenance including reports and amendments using Florence Healthcare eBinders; preparation for internal and external compliance reviews of FDA related regulatory documents; and assisting IND/IDE Study UW clinical Principal Investigators with protocol development for compliance with the Code of Federal Regulations.
$65,000 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps-understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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The Director of Quality & Regulatory reports directly to the VP, Medical Affairs. Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
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This position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of company pipeline compounds and products.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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8+ years of professional experience as either a healthcare litigation, regulatory, or transactional associate in a nationally recognized law firm, in-house counsel at a nationally recognized company or organization, or a combination thereof.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriad’s gene therapy product development, registration, and post-approval strategies.
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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs, Biocompatibility, and Toxicology. MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization.
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Job Title: Regulatory Affairs Manager. Provide CMC regulatory strategy input and expertise in investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidance.
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Square made credit card payments possible for all by turning a mobile phone into a credit card reader.
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regulatory job Title: regulatory affairs specialist Company: Jazz Pharma
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