IND/NDA Submissions Lead — Global PM

MMS; Seattle (WA); Remote; USD 120,000 - 150,000; Full time

Job summary

MMS Holdings Inc. is seeking a Regulatory Submissions Lead to plan and coordinate IND, NDA, and MAA submissions. You will work with clinical, biometrics, regulatory writing, and regulatory operations teams to ensure timely, compliant filings.

The role requires 5+ years in project coordination/management within pharmaceutical development and NDA/MAA experience. You will drive timelines, budgets, and client engagements in a globally distributed environment.

Qualifications

• Bachelor’s degree or equivalent in a relevant field; 5+ years in project coordination/management.
• Expert knowledge of pharmaceutical development phases and NDA structure; NDA/MAA filing experience preferred.
• Experience developing and managing integrated regulatory submission plans with timelines, dependencies and risks.
• Strong organizational and communication skills, with ability to align stakeholder needs with practical solutions.
• Experience managing budgets, invoicing, profitability, margins, and utilization, with financial analysis ability.

Responsibilities

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Collaborate with cross-functional teams to identify dependencies and mitigate risks for submissions.
• Develop and maintain detailed submission timelines, critical paths, and resource needs.
• Oversee multiple client engagements and complex workloads to meet deadlines.
• Lead project discussions, build consensus, and provide status updates to stakeholders.
• Manage project budgets, revenue recognition, invoicing, profitability, margins, and utilization.
• Contribute to RFP scoping and communicate MMS's value in business discussions.
• Partner with clients to understand needs and present practical business solutions.
• Identify opportunities to improve client satisfaction and long-term relationships.
• Facilitate effective meetings with remote and global teams and promote collaboration.
• Support continuous process improvements for project delivery.

Skills

Regulatory submissions planning

Cross-functional leadership

Pharmaceutical development knowledge

Project coordination

Stakeholder communication

Education

Bachelor’s degree or equivalent

Job description

MMS Holdings Inc. is seeking a Regulatory Submissions Lead to plan and coordinate IND, NDA, and MAA submissions. You will work with clinical, biometrics, regulatory writing, and regulatory operations teams to ensure timely, compliant filings.

The role requires 5+ years in project coordination/management within pharmaceutical development and NDA/MAA experience. You will drive timelines, budgets, and client engagements in a globally distributed environment.