Degree in life sciences, pharmacy, medicine or a related scientific discipline
Significant progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry, with strong expertise in European drug development and registration.
Demonstrated experience, including substantial involvement in strategy, dossier preparation, submission and health authority review.
Practical experience preparing and coordinating responses to assessment questions and interacting with regulatory authorities.
Strong knowledge of pharmaceutical legislation, procedures, ICH guidelines, GCP and applicable regulatory requirements.