Regulatory Submissions Project Manager

Job Summary

To support regulatory submission initiatives, the full-time Regulatory Submissions Project Manager will lead the planning and preparation of IND, NDA, and MAA submissions while collaborating with cross-functional teams in a remote environment.

Key responsibilities

• Lead the planning and preparation of IND, NDA, and MAA submissions to regulatory authorities in partnership with functional leads
• Develop and maintain detailed submission timelines, including critical paths, resource needs, and contingency plans for tasks
• Oversee multiple client engagements and deliverables, ensuring timely completion while managing project budgets and profitability

Required qualifications

• Bachelor's degree or equivalent relevant experience with at least 5 years in project coordination or management
• Expert knowledge of pharmaceutical development phases and experience with NDA and MAA filings
• Demonstrated experience in developing and managing integrated regulatory submission plans
• Experience managing project budgets, invoicing, and analyzing financial performance
• Strong ability to lead client-facing discussions and collaborate with remote, global teams