Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role required
Experience supporting clinical development teams in the autoimmune disease space is a must
Provides regulatory guidance and input to project teams
Designs and implements regulatory strategies to obtain and maintain clinical trial applications
Oversees the creation and submission of all regulatory filings
Extensive knowledge of non-clinical and clinical development, regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA and other international regulatory agencies
Demonstrated track records of successful regulatory meetings, IND or BLA submissions and approvals
Experience in Oncology and Immuno-oncology is preferred but not required
Arranges for and leads meetings with global health authorities as needed
Provides training and mentorship to regulatory staff and other junior staff at the company