Sr. Director, Regulatory Affairs

Role Summary

The Senior Director of Regulatory Affairs is responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements. The ideal candidate will have a strong background in cell and gene-modified cell therapy, expertise in global regulatory requirements, and preferably late-stage development experience.

Responsibilities

• Support the preparation, review, and submission of regulatory filings, including INDs, CTAs, BLAs, and MAAs, ensuring compliance with global regulatory requirements.
• Assist in compiling and organizing regulatory documents and responding to health authority queries.
• Work closely with cross-functional teams, including Clinical, Pharmacovigilance, Biometrics, and CMC, to ensure accurate and complete regulatory submissions.
• Maintain up-to-date knowledge of global regulatory requirements and contribute to regulatory intelligence efforts.
• Support regulatory interactions with global health authorities by preparing meeting materials and responses to requests.
• Contribute to the development of regulatory documentation, including CTD dossiers, IBs, clinical protocols, nonclinical and clinical study reports.
• Assist in tracking regulatory commitments and timelines to ensure timely submissions and approvals.
• Provide hands-on support in assessing emergent clinical data and operational activities for regulatory compliance.

Education

• Bachelor’s degree required; advanced degree preferred.

Qualifications

• Required: 10+ years’ experience in a fast-paced, high-volume document production environment (e.g., documentation, publications, formal meetings) with at least 5 in the cell and gene therapy space.
• Strong knowledge of regulations and guidelines across multiple global jurisdictions, including the U.S., EU, and other key regulatory agencies.
• Hands-on experience in the preparation and submission of regulatory filings (e.g., INDs, CTAs, BLAs, and MAAs).
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities effectively.
• Excellent written and verbal communication and collaboration skills to work effectively with cross-functional teams.
• Ability to thrive in a fast-paced environment and adapt to changing regulatory requirements.