Support in Regulatory Affairs in EU, UK, Switzerland and the non-EU Balkan countries Reference number: 2238

  • Online since: 16-03-2022
  • Sector: Pharma
  • Start: 03-04-2022
  • Category: Other

Job description

Support RA activities in the EU, UK, Switzerland and the non-EU Balkan countries for products approved through the centralized and decentralized/MRP procedures – in collaboration with the Regulatory Liaison.

What you'll do

  • Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements
  • Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
  • Drafts of module 1 components and organizing the gathering of the module 1 components.
  • Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
  • Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
  • For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
  • Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
  • Ensures updates to regulatory databases.

Profile

  • University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
  • Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
Apply now
Laura Bral Recruiter
02 629 77 72
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