Regulatory Submissions Project Manager

Job Summary

Leading the planning and execution of major global marketing applications, the contract Regulatory Submissions Project Manager will manage critical NDA, BLA, MAA, and IND/CTA filings in a fully remote environment.

Key responsibilities

• Lead end-to-end planning and execution of regulatory submissions, ensuring compliance and quality
• Develop and maintain integrated submission plans, milestones, and risk logs to support timely delivery
• Coordinate cross-functional content readiness and facilitate governance and communication with stakeholders

Required qualifications

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline
• 8+ years of relevant experience in pharmaceutical, biotechnology, or life sciences regulatory submissions project management
• Demonstrated experience leading major regulatory approval filings such as NDA, BLA, MAA, and IND/CTAs
• Experience in a matrixed global development environment supporting complex cross-functional teams