Regulatory Affairs development professional with  over twenty years of experience in pharmaceutical industry, with multi-functional expertise in Regulatory Affairs (clinical, nonclinical and CMC). Primary focus is to help clients develop and execute regulatory strategy through product approval. Strengths include a strong technical background in pharmaceutical development for small molecule, biologics, and combination products development.  Experienced in negotiating with US and international regulatory authorities.  Accomplishments include IND/CTA/NDA/DMF filings and maintenance, NDA/MAA preparation, review and planning, orphan drug designation, successful interactions with US and EU Health Agencies.