Regulatory Affairs Officer

€45000 - €46000 per annum
  1. Permanent
  2. Officer /Associate
  3. Germany
Munich, Germany
Posting date: 12 Mar 2021

An excellent opportunity for a talented and self-motivated Regulatory Affairs Officer to join an expanding team in Germany. You will be provided with a wide variety of experience in regulatory projects within different therapeutic areas. You will work directly with clients, handling tasks with minimum supervision and interacting professionally at multiple levels within client organisations.

Job Responsibilities

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Skills and Requirements

  • M.Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Fluent in German and English
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organisational skills with attention to details
  • Willingness to work from client sites, when required

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.