Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998

Role: Director, Regulatory Affairs Clinical Strategy at Ascendis Pharma, focusing on developing and executing global regulatory strategies across clinical, non-clinical, and CMC areas for innovative biopharmaceuticals. Responsibilities include guiding global regulatory planning, preparing complex submissions, managing regulatory interactions, and translating regulatory requirements into actionable project plans, with a focus on investigational and marketed products. The role involves contributing to global labeling, risk mitigation, and staying abreast of evolving regulations. Qualifications: minimum 10 years of regulatory experience, Bachelor's degree, expertise in regulatory requirements including ICH and regional standards, and experience managing regulatory dossiers like CTAs, INDs, IMPDs, and BLA/NDA submissions. Experience with drug-device combination products and international teams is preferred. The position requires ability to lead cross-functional teams, review technical documents critically, and travel up to 20%. The role is based in Palo Alto, CA, with a focus on rare disease and oncology programs, employing innovative strategies and cross-functional collaboration to support clinical development stages from IND to post-market. High-value specifics include experience with regulatory filings and strategic input for clinical and CMC disciplines in a fast-growing, science-driven environment.