Regulatory Submissions Project Lead (IND/NDA/MAA) – Global

MMS Holdings Inc; Raleigh (NC); Hybrid; USD 110,000 - 150,000; Full time

Job summary

MMS Holdings Inc. is a data-focused CRO delivering regulatory submission services for pharma, biotech, and medical device clients.

This role leads IND, NDA, and MAA submissions, coordinating across clinical, biometrics, regulatory writing, and operations to meet deadlines. The successful candidate will manage complex, high-volume workstreams, develop submission plans, and guide client engagements with remote and global teams.

Qualifications

• Bachelor's degree or equivalent experience.
• 5+ years in project coordination/management.
• Expert knowledge of pharmaceutical development phases and NDA structure.
• Experience with integrated regulatory submission plans.
• Strong organizational and communication skills.

Responsibilities

• Lead planning and preparation of IND, NDA, and MAA submissions.
• Coordinate with cross-functional teams to meet deadlines.
• Develop and maintain submission timelines and critical paths.
• Manage multiple client engagements and concurrent deliverables.
• Provide project metrics, status updates, and risk reports.
• Oversee project budgets, profitability, and utilization.
• Support RFP scoping and articulate value proposition.
• Foster effective collaboration across remote and global teams.

Skills

Regulatory submissions

Cross-functional leadership

Budget management

Risk management

IND/NDA/MAA filings

Pharma development knowledge

Remote/global collaboration

Project coordination

Stakeholder communication

Education

Bachelor's degree or equivalent

Job description

MMS Holdings Inc. is a data-focused CRO delivering regulatory submission services for pharma, biotech, and medical device clients.

This role leads IND, NDA, and MAA submissions, coordinating across clinical, biometrics, regulatory writing, and operations to meet deadlines. The successful candidate will manage complex, high-volume workstreams, develop submission plans, and guide client engagements with remote and global teams.