RA Coordinator

Reference: HAR-15-041

Client

Our client is a global pharma company located at the east side of Brussels.

This function is office based.

Main purpose

  • To provide procedural, administrative and planning support for submissions

 

Tasks

  • 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
  • Tto 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

 

Requirements

  • University degree (or similar such as A1 in Belgium), 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 asset
  • Good understanding of the end-to-end pharmaceutical lifecycle
  • At least 2 years experience in Regulatory Affairs

Apply for this position