Regulatory Affairs Coordinator

Brussel  ‐ Onsite
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Keywords

Description

For one of my best clients I am actively looking for a Regulatory Affairs Coordinator for a challenging opportunity in a communicative company leader in its market.

Start: ASAP

Duration: 1 year ( +extension)

Location: Brussels

Description:

As a Regulatory Affairs Coordinator you will be in charge of the following tasks:

Primary activities of EMEA Regulatory Coordinator:

  • To provide procedural, administrative and planning support for new submissions and variation submissions in the EU, 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

Skills:

  • University degree or similar (such as A1 in Belgium),
  • Preferably at least two years of experience in the pharmaceutical industry with knowledge about regulatory affairs
  • Experience with project management is an asset
  • Good understanding of the end-to-end pharmaceutical life cycle
  • Excellent written and verbal English is a must; other European languages are an asset

Interested? Please send me your CV immediately

Start date
ASAP
Duration
1 year
From
Clearsource
Published at
05.12.2014
Project ID:
818858
Contract type
Freelance
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