• Experienced Regulatory CMC leader in both drug development and life cycle management space. - Demonstrated strategist for both development programs and new product global registrations through comprehensive risk analyses and mitigation planning. - Seasoned writer for Regulatory CMC submission documents, including global IND/IMPD, NDA/MAA, responses to Health Authority review queries, and post approval variations. - Skilled reviewer for regulatory dossiers aiming to enhance probability of success while maintaining consistency with company’s business objectives. - Extensive experience in direct interactions and strategic negotiations with Health Authorities (including but not limited to, FDA, EMA, Health Canada and PMDA).• Strong project management skills through effectively communicating with internal and external stakeholders. Membership/leadership on numerous company-wide development governance teams.• Solid CMC technical knowledge in both research and manufacturing settings. In-depth understanding of quality and compliance aspects of the pharmaceutical business.
Listed skills include Pharmaceutical Industry, Fda, Regulatory Submissions, Regulatory Affairs, and 5 others.
