Julia Clive, Senior Consultant, is a seasoned regulatory affairs leader with more than 15 years of experience in the development and post-marketing of small molecules and biologics across a wide range of therapeutic areas including rare disease, neurology, rheumatology, immunology, pulmonology, cardiology, opthalmology, nephrology, gastroenterology, 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.
Julia has served as head/interim head of regulatory and is adept at providing high-level cross-portfolio strategic insight as well as hands-on support to achieve regulatory milestones. She has experience leading local and global cross-functional teams, as well as local and remote management of regulatory staff.