Julia Clive

Julia Clive, Principal Consultant, Global Regulatory Affairs, is a seasoned regulatory affairs leader with almost 20 years of experience in the development and post-marketing of small molecules and biologics across a wide range of therapeutic areas including rare disease, pulmonology, rheumatology, immunology, cardiology, nephrology, neurology, gastrointestinal, acute and chronic pain management, dermatology, hematology, and infectious disease.

Julia has served as regulatory strategy lead at pharma and biotech companies ranging in size from start-ups to large multinational organizations across all stages of product development. She has led the preparation of INDs, Pediatric Study Plans (PSP), Pediatric Investigational Plans (PIPs), requests for Orphan designation, Fast Track designation, Breakthrough designation, PRIME, and other submissions.  Julia has led and prepared teams for regulatory interactions such as pre-IND, EOP, Scientific Advice, and pre-NDA/BLA/MAA/NDS meetings.  Her background also includes label development and preparation, review, and defense of marketing applications.