Compliance

• Serve as the strategic and operational leader responsible for developing and executing global regulatory strategies to support clinical development, registration, and commercialization of the company’s pipeline
• Provide leadership and direction to internal teams and external partners, ensuring regulatory compliance and fostering effective interactions with global health authorities
• Report to the Chief Scientific Officer and work in close partnership with the VP of Clinical Operations, VP of Clinical Development, and VP Research & Preclinical
• Develop and implement global regulatory strategies aligned with corporate objectives for preclinical, clinical, and commercial programs
• Lead preparation and submission of INDs/CTAs, BLAs/NDAs/MAAs, and other key filings
• Anticipate and mitigate regulatory risks; provide proactive guidance on evolving regulatory landscapes
• Oversee all regulatory submissions, ensuring completeness, accuracy, and compliance with applicable regulations
• Manage regulatory documentation systems and ensure inspection readiness
• Lead interactions with external consultants, CROs, and regulatory agencies
• Partner closely with Clinical Development, CMC, Nonclinical, and project teams to align regulatory strategies with development plans
• Serve as a trusted advisor to senior leadership on regulatory implications of corporate decisions

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