Biography

"Highly experienced (bio)pharmaceutical consultant with extensive knowledge in the preparation of medical, CMC and regulatory documentation and strategies (full PLC) for all regions. Medical and technical writer of scientific regulatory documentation (full CTA, NDA, MAA, safety, labelling and CMC post - approval packages) and managerial level reports for pharma, medical devices and food supplements. Experienced in budgeting, strategic and statistical analysis in R, with problem solving skills to complement advanced project management and financial knowledge.