With over 18 years of experience in the pharmaceutical industry, I am a seasoned New Product Development Manager at Bimeda. I lead a team of talented scientists in the formulation, process and analytical development of generic finished dosage forms, both sterile and non-sterile, for various therapeutic areas and markets.My core competencies include pharmaceutical process development, manufacturing process improvement, and analytical method development and validation. I am the key contributor to CMC sections for FDA and EMA new drug submissions adhering to (V)ICH guidelines, and part of the R&D/Regulatory group responsible for submission and incomplete response strategy resulting in over 20 successful new drug approvals in the past 10 years. I am a dedicated leader and understand and foster a culture of collaboration across departments, and innovation within the Team I manage. My mission is to deliver high-quality drug products that meet the needs of our customers and patients, while empowering my Team to perform at their best potential.