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FREELANCE: Regulatory Affairs Coordinator - Belgium - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresBelgium,
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FREELANCE: Regulatory Affairs Coordinator - Belgium

Nr ref.: /JOBS.pl

  • Regulatory Coordinator - EMEABelgiumMy client is a truly global and highly prestigious pharmaceutical company. We are urgently seeking a Regulatory Coordinator to join their EMEA team, with any successful applicant to be office based in Belgium. The initial contract will be for 12 months with long term plans for extension.Role and responsibilities: * Provide procedural, administrative and planning support for new submissions and variation submissions in the EU (including Norway and Iceland), Switzerland and the non-EU CES countries for products approved through the Centralized, Mutual Recognition and Decentralized procedures * Provide administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements * Plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission * Draft module 1 components and to organize the gathering of the module 1 components * Collaborate closely with Regulatory Operations to establish submission timelines and content of Module 1 * Collaborate closely with subsidiary Registration Managers in order to ensure timely submission * Prepare the English Product Information (SmPC, label and leaflet) in collaboration with WPL * Centralized procedure: to supervise and coordinate the translation process to ensure timely submission to EMA * Administrative support related to Marketing Authorization Applications to Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed * EU procedural requirements and legislation * Subject Matter Expert in relevant work streams / projects as deemed appropriate by Regulatory Affairs Europe Senior Staff * Lead regional submission cross-portfolio planning team meetings; agenda, decisions, action itemsRequires skills and qualifications:• University degree preferably in a science related to medicine, and at least two years of experience in the pharmaceutical industry with knowledge about regulatory affairs.• Excellent written and verbal communication skills in English is a must; other European languages an assetFor the right candidate the organisation are happy to offer a strong and competitive daily rate, with a good chance of long term contract extension based on individual performance. To apply for this position and put yourself under immediate consideration, send your CV to or call (0)


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