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Director of Regulatory Affairs

2 months ago

Boston, United States Meet Full time

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.