Regulatory Affairs Consultant

• Support global regulatory strategy and execution for U.S. and ex-U.S. programs.
• Lead and coordinate IND/CTA submissions, protocol amendments, and responses to health authority queries.
• Manage submission timelines, tracking tools, and cross-functional project coordination.
• Collaborate closely with Clinical, CMC, Nonclinical, and external vendors to ensure high-quality regulatory deliverables.
• Assist with document authoring, QC review, and submission-readiness activities.
• Knowledge of U.S. regulatory submissions and eCTD format is strongly preferred.

• 3+ years of Regulatory Affairs experience within biotech or pharma.
• Experience preparing and supporting U.S. submissions (INDs, amendments, meeting packages).
• Strong project management skills with the ability to drive timelines and deliverables.
• Ability to work independently and effectively within a small, dynamic biotech environment.
• Excellent communication, organizational skills, and strong attention to detail.
• Biological logic development
• An important requirement is a small-molecule drug development experience.

Thanks

Vimal Jeeva