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Regulatory Affairs Project Manager - Oferta z Jobs.pl

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Regulatory Affairs Project Manager

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  • Regulatory Affairs Project Manager - 12 Month Contract- Germany Level: Regulatory Affairs Project Manager Contract: 12 months minimum Location: Germany, EU Summary We are looking for a Regulatory Affairs Project manager with commercial experience to work with a renowned pharmaceutical company. The successful candidate will have full life cycle management experience and proven experience in project management. This is an immediate start role; the details are as follows… Responsibilities * Proven experience in project management, and experience developing and implementing strategies at regional level * Act as regulatory representative across cross functional team's e.g. Medical team, drug safety, quality etc… * Planning, compiling and reviewing submissions activities for EU and non- EU CES countries * Experience with Centralised procedure, MRP & DCP submissions * Ability to develop and contribute regulatory strategy * To plan and coordinate new submissions of variations and MAA * To operate as a subject matter expert in relevant project * Supervise and coordinate translation process for Centralised procedure * Manage interactions with EU regulatory authorities * Keep up to date with EU regulatory requirements * Act as project manager lead for regional submissions * Maintain and update dossier for existing MAA and partake in customer audits * Review new and existing EU regulatory guidance documents, and prepare comments on new documents as needed * Maintain and update regulatory files, records and IT systems, databases used within GRA&QA (D2, RIMS, Eldorado, etc) Education * Degree in relevant qualification e.g. Masters or PhD in Pharmacy, Biology etc… * Minimum 5 years experience in Regulatory Affairs * Excellent written and verbal communication in English (other European languages such as German is a bonus) * Good understanding of End to End pharmaceutical life cycle * Experience liaising with regulatory authorities * Proven project management experience * Maintain and update regulatory files, records and IT systems, databases used within GRA&QA (D2, RIMS, Eldorado, etc) This is a 12 Months contract with a strong possibility of an extension; please make and application or contact: Amie Touray Hydrogen Group #LI-AT1


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