Director US Regulatory Affairs

Director, US Regulatory Affairs

Position Summary

This role is responsible for providing strategic regulatory leadership and oversight for U.S. regulatory activities across a clinical-stage portfolio. The individual will lead the preparation, execution, and lifecycle management of regulatory submissions, including clinical, nonclinical, and commercial components such as labeling and promotional materials.

This position will serve as the primary liaison with the U.S. Food and Drug Administration (FDA) and will partner closely with cross-functional stakeholders to support development programs from early stage through potential approval and commercialization. The role reports directly to the Head of Regulatory Affairs.

Key Responsibilities

• Lead and manage regulatory projects, including development of submission timelines and ensuring alignment with broader corporate milestones
• Oversee preparation, review, and submission of INDs, NDAs, and lifecycle submissions, including safety reporting and regulatory maintenance activities
• Direct the planning, authoring, and submission of regulatory meeting requests and briefing documents; coordinate and lead FDA interactions
• Contribute to and help shape global and U.S. regulatory strategies aligned with development and commercialization objectives
• Interpret and apply FDA regulations and guidance, providing regulatory intelligence and strategic recommendations to senior leadership
• Represent Regulatory Affairs in cross-functional discussions and external meetings with health authorities, including negotiation of regulatory pathways and issue resolution
• Support development and continuous improvement of regulatory processes, systems, and SOPs
• Lead or contribute to additional regulatory initiatives as required

Qualifications & Experience

• Bachelor's degree in a scientific or healthcare-related discipline with at least 6 years of regulatory affairs experience in the biotechnology or pharmaceutical industry; advanced degree (PhD, MD, PharmD) preferred with comparable experience
• Hands on experience filing marketing applications in the US (NDA submission experience preferred)
• Demonstrated experience managing U.S. regulatory submissions, including eCTD preparation and agency correspondence
• Strong working knowledge of FDA regulations across clinical development, marketing applications, and post-approval requirements
• Experience as a direct point of contact with FDA and serving as the US Regulatory liaison is preferred
• Experience supporting or reviewing advertising and promotional materials for prescription products is a plus
• The ideal candidate will have experience leading clinical and nonclinical strategies
• Proven ability to manage multiple projects simultaneously in a fast-paced, evolving environment
• Strong project management, organizational, and problem-solving skills
• Excellent written and verbal communication skills with the ability to effectively interact with internal teams and regulatory agencies
• Collaborative, proactive, and solutions-oriented mindset

*Must be based in EST timezone to be considered for this position