Our client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams, this position requires flexibility and strong cross-cultural communication skills.
Key Responsibilities
Lead US NDA submissions, including FDA interactions and dossier preparation.
Ensure post-approval regulatory compliance.
Act as primary regulatory contact with the FDA across the portfolio.
Develop and implement clinical regulatory strategies; support risk mitigation.
Oversee all FDA submissions for assigned products.
Provide regulatory support for new compounds and line extensions.
Contribute to due diligence assessments and internal policy development.
Ideal Candidate Profile
Education: Advanced degree in natural sciences.
Experience: 10+ years in pharma/biotech regulatory affairs with NDA leadership experience in the US.
Skills: Strong communication, leadership, and team collaboration abilities; experience with anti-infectives a plus.
Why Join?
Innovative Culture: Collaborative, growth-oriented, and science-driven environment.
Flexibility & Benefits: Hybrid work options, competitive benefits, and support for work-life balance.