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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments.
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The Customer Care Agent is responsible for effectively resolving consumer inquiries and complaints and the receipt, documentation, classification, and processing of product complaints within regulatory guidelines for North America.
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Works closely with quality, manufacturing, Global Regulatory Affairs (GRA), and technical staff from global locations within industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers.
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The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.
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This position reports to the VP, Global Regulatory Affairs. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA considered a plus. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA, supplements, annual reports as well as the rapid and efficient turnaround of time-sensitive submissions.
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Provide support in software validation and migration activities relating to new or existing systems in Regulatory Affairs. The Manager, Regulatory Operations will be responsible for functional activities related to US/Ex-US regulatory submissions.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches.
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Sanofi Global Regulatory Affairs, Global Labeling team is looking for a motivated individual to help lead labeling strategy for products in the rare blood and rare disease portfolio. Practical experience in Regulatory Affairs, Pharmacovigilance, or Medical Affairs.
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The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). The role will own the effort across Medical Affairs projects to identify, initiate, develop, and implement programming standards, applications, processes, and training.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
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Must have experience collaborating with other teams such as Regulatory Affairs, Clinical Development, Quality Assurance, Legal, Clinical Operations, etc. Serve as the GLP/GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs and ICH Guidelines.
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regulatory affairs jobs Title: sr regulatory affairs associate in Bedminster, NJ
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