Remote Project Manager - Regulatory Submissions

MMS Holdings Inc; Northern (KY); Remote; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc. seeks an experienced Regulatory Submissions Lead / Project Manager to coordinate IND, NDA, and MAA submissions with cross‑functional teams across clinical, biometrics, regulatory writing, and operations.

You will develop submission timelines, manage dependencies and risks, oversee multiple client engagements, and monitor budgets, revenue, and utilization to ensure timely, compliant deliverables. The role emphasizes leadership of remote and global teams.

Qualifications

• Bachelor's degree or equivalent with at least 5 years in project coordination or 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, risks, and contingencies.
• Strong organizational and communication skills; ability to lead cross-functional teams and manage client initiatives.

Responsibilities

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Partner with cross-functional clinical, biometrics, regulatory writing, regulatory affairs, and operations teams to identify dependencies, mitigate risks, and meet deadlines.
• Develop and maintain detailed submission timelines, dependencies, critical paths, resource needs, and contingency plans.
• Oversee multiple client engagements and a high-volume workload to meet submission deadlines.
• Lead project discussions, track progress, and provide status updates to stakeholders with metrics.
• Manage project budgets, revenue recognition, invoicing, profitability, margins and utilization.
• Contribute to RFP scoping and communicate the company's value proposition in discussions with clients.
• Identify opportunities to improve client satisfaction and deliver practical business solutions.
• Facilitate effective meetings with remote and global teams, promote collaboration and resolve conflicts.
• Support continuous improvement of project processes and outcomes.

Skills

Regulatory Submissions

Cross-functional Leadership

Budgeting

Client Communication

IND/NDA submissions

Project Management

Education

Bachelor's degree

Job description

MMS Holdings Inc. seeks an experienced Regulatory Submissions Lead / Project Manager to coordinate IND, NDA, and MAA submissions with cross‑functional teams across clinical, biometrics, regulatory writing, and operations.

You will develop submission timelines, manage dependencies and risks, oversee multiple client engagements, and monitor budgets, revenue, and utilization to ensure timely, compliant deliverables. The role emphasizes leadership of remote and global teams.