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In addition, the incumbent will work closely with the Sanofi Vaccines Research and Development, Public Affairs, Regulatory Affairs, Commercial, Value and Access and Franchise and Product Strategy functions globally to support optimal life cycle management for all products.
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management,Commercial and Operations functions.
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Manage the enrollment center welcome area daily operations providing excellent customer service to triage guests including flow of traffic throughout the enrollment funnel (admissions, recruitment & communications, enrollment services, financial aid, bursar/cashier-student accounts, student affairs, and academic affairs, etc.
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Key partnerships include Commercial, Real-World Evidence, Commercial Analytics, Medical Affairs and Market Access as well as outside GCSO with regional Commercial and Medical/Scientific Affairs teams, J&JIM R&D, J&J Technology (JJT) Data Sciences and broader J&JIM teams, and others.
$142,000 - $244,950 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Support/participate in external regulatory audits (FDA, TUV, Health Canada, Customers, etc.
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Interact with Regional Market Access/Health Economics / Outcomes Research and Medical Affairs teams to coordinate and develop real world evidence generation in support of their access programs.
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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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This means that, in addition to our blockchain expertise, part of our operational needs are very similar to that of a traditional investment manager: trade management, service provider relations, book reconciliation, audit, tax, and regulatory compliance, and the like.
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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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Global Scientific Communications and Publications has responsibility for the development and delivery of internal and external scientific communication strategy and related tactics including global publications (e.g., abstracts, posters, manuscripts) and scientific materials such as slide decks for use by Medical Affairs around the world.
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Minimum of 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.
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Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
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This position reports to the VP, Global Regulatory Affairs. Regulatory Affairs - Bridgewater, NJ - Full Time Summary. 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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regulatory affairs jobs Title: sr regulatory affairs associate in Somerville, NJ
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