Pharma – Regulatory Affairs RA Submission Associate

Pharma – Regulatory Affairs RA Submission Associate

 

Core Mission

To support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products (prescription drugs) mainly for international countries (excluding US) and  ad-hoc support for European countries.

 

Activities and responsibilities

  • Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
  • Assure timely receipt and dispatch of administrative documents and their legalization (if applicable) necessary for registration, renewal and variation files (including but not limited to Certificate of Pharmaceutical Products, Free Sale Certificates, Letter of Authorization, GMPs, Price certificates)
  • Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update

 

Work Experience

  • 1-2  year’s experience in regulatory affairs, ideally in a global organization for international countries such as Middle East, CIS or Latin America
  • Experience in a multinational environment
  • Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database

 

Required Skills and Knowledge

  • BSc in Scientific or equivalent experience
  • Planning, organizing and time management skills
  • ability to deal with rapid change
  • Fluent in English; French and/or Spanish is a plus

Please send your CV to Jean de La Fournièere at jean@axepta.com

Jean De La Fourniere delafourniere@axepta.com