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We are rapidly expanding and are looking for an experienced Quality & Regulatory Affairs Manager with experience of managing Class I, II, medical devices. As Regulatory Affairs Specialist you will be a key contributor to the success of the Quality Assurance and Regulatory Affairs (QARA) within the company, helping to ensure compliance to all applicable regulations, standards, and guidance by maintaining regulatory documentation, managing assigned processes, and representing Regulatory Affairs in key business projects.
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Lead and manage projects involving Real World Evidence (RWE), integrating these insights with Regulatory Affairs to optimise early access programmes. Design and implement strategies to gather and utilise real-world data, supporting regulatory submissions and enhancing drug development processes.
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Job Title: Regulatory Affairs CMC Manager. Manages strategy and execution for all regulatory CMC submissions (e.g. late-stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
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Proclinical is seeking a dedicated and detail-oriented individual for the role of Regulatory Affairs Manager. This role offers an exciting opportunity to manage a subteam within the Regulatory Department, providing exposure to various aspects of regulatory affairs from clinical trials to lifecycle management in medicines and medical devices.
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The Regulatory Affairs Manager will play a vital role in supporting the product, marketing and management teams to stay informed with changes in the regulatory reporting market so they can perform their necessary functions.
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A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities.
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Are you a Regulatory Affairs Manager with Food & Beverage industry experience looking for a new opportunity and to join a growing and exciting organisation? Determining and/or validating existing regulatory information including legal ingredient declarations, allergen information, nutritional, analytical tolerances, suitability based on product composition in our online formulation repositories.
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Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract. Previous experience in international Regulatory Affairs and Compliance particularly within the pharmaceutical industry.
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Preventing any successful challenge to our products, packaging, labels and documentation from a Regulatory. Certifying audits (Kosher, Halal, Fair Trade and Soil Association etc.) Support the compliance and approval of appropriate Synergy products to 3rd party certification requirements (Organic/Halal/Kosher/FairTrade.
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We are recruiting for a Regulatory Affairs Manager - EU. The role reports to Director of Regulatory Affairs and is based in our offices near High Wycombe managing a small team.
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Due to recent success within one our Innovative Biotech Clients I am recruiting for a Regulatory Affairs manager at ICON - Working in a client-dedicated yet fully embedded role ICON’s Regulatory Strategy group, you will lead or contribute to the development and execution of the drug development strategy of our client’s new therapeutics.
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Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. Regulatory Affairs Manager (Inside IR35.
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