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Author product statements and documentation in compliance with international and country specific legislation (e.g. product dossiers, registration certificates) with the support of the SDS authoring specialist for label data, GHS classifications, Dangerous Goods classifications, worker safety or environmental risk assessments and with the support of the Regulatory affairs team for site specifics and environmental regulation.
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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.
$200,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.
$165,000 - $231,667 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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Sanofi is recruiting a new Global medical Director to support post- regulatory authorization clinical trial program for dupilumab in the Global respiratory Franchise for the respiratory indications including asthma and Chronic Obstructive Pulmonary Disease (COPD) for dupilumab and itep.
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Demonstrated experience working with routinely collected data (claim databases, electronic medical (health) records, registries), and various structured and possibly unstructured data sources in the healthcare sector within pharmaceutical companies’ settings in commercial market access, medical affairs, scientific affairs and/or R&D environment.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements. Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.
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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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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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Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE, Series 7 Top Off and Series 66 licenses, fully paid for and sponsored by Fidelity.
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In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.
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10 years within the pharmaceutical/biotech industry is required, along with a minimum 5 years of recent regulatory affairs experience. Global Regulatory Affairs, R&D or health authority role) is required.
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Build and Solidify Skills: You’ll continue to spend four days a week working from home and one day a week in an Investor Center, where you’ll support customers with increasing complexity to develop and hone your skills.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Abbott Laboratories in Neshanic Station, NJ
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