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Regulatory Affairs Specialist EMEA - Oferta z Jobs.pl

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Regulatory Affairs Specialist EMEA

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  • Regulatory Affairs Specialist EMEA- 12 Months Contract- Immediate start Belgium Level: Regulatory Affairs Specialist EMEA Contract: 12 months' minimum Location: Germany, EU Summary We are looking for a Regulatory Affairs specialist with commercial experience to work with a renowned pharmaceutical company. The successful candidate will have sound knowledge in post approval regulatory activities. This position is based in the Belgium and the successful candidate must have excellent written and communication in English. Responsibilities * Planning, reviewing and coordination of submissions activities for EMEA 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 author module 1 of the CTD * Able to contribute across a cross-functional teams especially the operations team for timely submission * To operate as a subject matter expert in relevant project * Supervise and coordinate translation process for Centralised procedure * Able to provide advice across PIP or Orphan drugs * Manage interactions with EU regulatory authorities * Keep up to date with EU regulatory requirements * Act as project manager lead for regional submissions Education * Degree in relevant qualification * 3-5 years' experience in Regulatory Affairs * Excellent written and verbal communication in English (other European languages are a bonus) * Good understanding of End to End pharmaceutical life cycleThis is a 12 Months contract, please make and application or contact: Amie Touray Hydrogen Group #LI-AT1


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