Director of Regulatory Affairs

Position OverviewOur 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 ResponsibilitiesLead 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 ProfileEducation: Advanced degree in natural sciences.Experience: 10+ years in pharmabiotech 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.

Created: 2024-11-11