Degree in life sciences, pharmacy, medicine or a related scientific discipline; advanced degree preferred
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
Ability to interpret complex scientific and regulatory information and translate it into clear, actionable recommendations
Strong communication, influencing, negotiation and project leadership skills, with the ability to operate effectively across functions and organizational levels
Comfortable working independently, taking ownership of outcomes and remaining closely involved in key regulatory deliverables
Collaborative and solution-oriented, with intellectual curiosity, sound judgment and openness to alternative perspectives
Able to balance speed and pragmatism with scientific rigor, regulatory compliance and high-quality execution
Domestic and international travel may be required, anticipated at approximately 10–20%, depending on program and business needs