• Represent regulatory on cross-functional teams; provide leadership and strategic direction for regulatory deliverables. • Lead planning and provide 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. • Identify, communicate, and propose resolutions to routine and complex strategic issues. • Serve as primary contact and build trusted relationships with Health Authorities for assigned program(s). • Maintain expert knowledge in US and international regulations and provide proactive regulatory intelligence. • Assess opportunities and oversee applications for expedited pathways (e.g., fast track or breakthrough designation or PRIME) and/or orphan drug designations. • Lead preparation for and conduct of Health Authority meetings. • Evaluate competitive landscape, regulatory approval pathway(s), and labeling precedent(s). • Identify, engage and collaborate with external regulatory experts and consultants. • Perform regulatory strategic assessments for new product candidates and new indications. • Support departmental initiatives, including process and infrastructure development, regulatory intelligence, budgeting, and authoring of departmental documents (e.g., SOPs and Regulatory Development Plans).