(Sr) Regulatory Affairs Specialist (Biotechnology) – International Pharma / Madrid, Spain

On behalf of our Client who are an international Pharma Group currently going through a period of unprecedented expansion, I am looking for an experienced Regulatory Affairs Specialist to join their team in Spain developing biosimilars. In this role you will report to Head of Regulatory Affairs.

Responsibilities:

  • Analyzing global submission requirements and submitting regulatory dossiers
  • Preparation of submission files of new products with respect to local regulations
  • Monitoring, preparing and following-up on renewals for all registered products
  • Participation in various internal and external regulatory meetings as required
  • Maintenance of all files and documentation pertaining to regulatory activities
  • Dealing with queries from regulatory bodies and health agencies

Desired experience:

  • Educational background in life sciences
  • Min. 3 years of experience in regulatory affairs with large molecule / biologic drugs
  • Preferred experience of working with modules 3, 4 and 5
  • Experience of working with EMA and good knowledge of regulatory procedures in Europe
  • Fluency in English, Spanish would be an extra asset

In return you can expect an attractive remuneration and interesting international work environment. If you meet the above criteria and are interested, please send your up-to-date CV with contact details to candidates@pharmaprofessionals.eu

(Sr) Regulatory Affairs Specialist (Biotechnology) – International Pharma / Madrid, Spain was last modified: August 24th, 2017 by Admin