In the context of our growing activities, we are looking for a Regulatory Affairs Officer to join our teams in Germany.

Group 10

  • Contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Document and track regulatory submissions and regulatory authority approval inside document management systems.
  • Provide regulatory support to clients and associate companies
  • Liaise with sponsor head-office and affiliate departments on regulatory issues.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

Group 11
Education & Experience

  • Bachelor’s degree or more in a Life Sciences related field.
  • At least 1 year of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
  • Previous experience in a consulting company would be a plus

Group 13

Hard/Technical skills:

  • Native German mandatory along with fluent English
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel

Soft skills:

  • Excellent organizational skills
  • Ability to work well within a team
  • Process oriented with good attention to detail
  • Effective oral and written communication skills
  • Solution-driven

Regulatory Affairs Officer - 712