Senior Director, Regulatory Affairs

Represent regulatory on cross-functional teams, providing leadership and strategic direction for regulatory deliverables and hands-on support for development and on-time delivery of clear and persuasive global regulatory submission documents, including INDs/CTAs, DSURs, pediatric investigation plans (PIPs), responses to Health Authority (HA) queries, and briefing documents. You will serve as primary contact and build trusted relationships with Health Authorities for assigned program(s), maintain expert knowledge in US and international regulations, and assess opportunities and oversee applications for expedited pathways and/or orphan drug designations. You will also lead preparation for and conduct of Health Authority meetings.