Compliance

• 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).

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