EMEA Regulatory Coordinator

Quality by Design
Geplaatst op
Binnen een jaar
Op locatie


Primary activities

  • to 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

  • to provide administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements

  • to plan and coordinate new submissions, variations, CHMP referrals, FUM, in order to ensure timely submission

  • to draft module 1 components and to organize the gathering of the module 1 components

  • to collaborate closely with Regulatory Operations to establish submission timelines and content of Module 1

  • to collaborate closely with subsidiary Registration Managers in order to ensure timely submission

  • to prepare the English Product Information (SmPC, label and leaflet) in collaboration with WPL

  • for the centralized procedure: to supervise and coordinate the translation process to ensure timely submission to EMA

  • to provide other administrative support related to Marketing Authorization Applications to Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed

  • to ensure updates to regulatory databases

  • to keep up to date with EU procedural requirements and legislation

  • to participate as Subject Matter Expert in relevant work streams / projects as deemed appropriate by Regulatory Affairs Europe Senior Staff

  • to lead regional submission cross-portfolio planning team meetings; agenda, decisions, action items

  • to act as the regional point of contact (on status of regional regulatory milestones) for Business Owners

  • to assist Business Owner in resolution of issues identified with acceleration or delay of regulatory milestones

  • to interact as necessary with regional MMD planning and/or manufacturing sites regarding issues

Job Requirements

  • University degree (or similar such as A1 in Belgium), preferably in a science related to medicine

  • At least two years of experience in the pharmaceutical industry with knowledge about European regulatory affairs.

  • Excellent written and verbal communication skills in English is a must; other European languages an asset

  • Good understanding of the end-to-end pharmaceutical lifecycle

Personal Skills

-Good communication skills
-Good negotiation skills (Must be strong and confidence)
-Deal with issues independently

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