Responsibilities
- Serve as Regulatory Lead for biologics, focused on infectious diseases programs.
- Develop and execute global regulatory strategies across nonclinical, CMC, and clinical development.
- Lead preparation, authorship, and coordination of regulatory submissions, including pre‑IND packages, INDs, amendments, and briefing documents.
- Direct interactions with FDA and other health authorities; prepare teams, lead discussions, and manage responses to queries.
- Lead cross-functional regulatory efforts by partnering with nonclinical, CMC, clinical, project management, and external partners/CROs.
- Assess regulatory risks, impacts, and mitigation options; communicate recommendations to internal teams and senior leadership.
- Ensure compliance with FDA, ICH, and global regulatory requirements, as well as internal SOPs and GxP standards.
- Oversee regulatory documentation quality and timely delivery of program milestones.
Work Arrangement
Hybrid
Team
Structure: Cross-functional leadership role partnering with nonclinical, CMC, clinical, project management, and external partners/CROs
