Position Overview
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.