Senior Director/Vice President, Regulatory Affairs

Role Summary

The Senior Director/Vice President of Regulatory Affairs will 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. This individual will provide leadership and direction to internal teams and external partners, ensuring regulatory compliance and fostering effective interactions with global health authorities. Reporting to the Chief Scientific Officer, this position will work in close partnership with the VP of Clinical Operations, VP of Clinical Development and VP Research & Preclinical to ensure seamless execution of Korro's preclinical and clinical regulatory strategy.

Responsibilities

• Develop and implement global regulatory strategies aligned with corporate objectives for preclinical, clinical, and commercial programs.
• Serve as the primary regulatory contact for internal teams and health authorities (FDA, EMA, MHRA, PMDA, etc.).
• 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.
• Lead and execute in a lean organization while demonstrating hands-on, strong, cross-functional leadership across the organization to drive regulatory objectives and outcomes.
• Contribute to corporate strategy and participate in executive-level decision-making.

Regulatory Operations

• 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.
• Oversee development of labeling, promotional materials, and product claims.

Cross-Functional Collaboration And Leadership

• 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.
• Foster a culture of accountability and innovation.
• Provide regulatory input to support business development and partnership activities.
• Mentor and develop peers to support both operational excellence and career growth.

Qualifications

• Advanced degree (PharmD, PhD, MD, or MS) in life sciences or related field.
• 12+ years of progressive regulatory affairs experience in the biopharmaceutical industry, including leadership of regulatory strategy and submissions.
• Successful track record of interactions with FDA and global agencies, and experience leading major submissions (INDs, NDAs, BLAs, MAAs).
• Experience across multiple phases of development (preclinical through post-approval) strongly preferred.

Skills

• Deep understanding of global regulatory frameworks and guidelines.
• Proven ability to lead cross-functional initiatives and manage complex regulatory programs.
• Strong communication and interpersonal skills, with executive presence.
• Ability to thrive in a fast-paced, dynamic, and science-driven environment.

Education

• As listed in Qualifications.

Additional Requirements

• $250,000 - $350,000 a year