Regulatory Expert
As a Dossier Development / Regulatory Expert you will be responsible for compiling (parts of) regulatory dossiers submitted for clinical trial applications with main emphasis on IND and IMPD, but potentially extended with additional markets. You will work in an R&D team covering chemical/synthesis process and analytical development of active pharmaceutical ingredients in the different clinical phases of pharmaceutical development and you will act as an expert regulatory consultant for Customers in a CDMO environment. Additionally, you will also be responsible for the knowledge management of dossier-centric development principles and follow-up on regulatory expectations in the related areas.
The position can be filled from Hungary / France / or Germany.

Expectations:

• Master’s degree or PhD in Chemistry, Pharmaceutical Sciences or Biotechnology/Engineering
• At least 5 years experience in CMC Regulatory Affairs (experience in different phases of clinical development is an advantage)
• Knowledge of regulatory expectations for different clinical phases
• Advanced technical writing skills in English
• Fluent in English
• Innovative thinking and good troubleshooting skills
• Good communication skills
• Good time-management and prioritization skills

What we can offer you

• A competitive annual salary
• Annual bonus
• A fantastic, supportive team and professional development
• Other benefits depends on your country and will be part of the official offer

Please refer the Job description for details