Global Regulatory Submissions Project Lead

MMS; Canton Charter Township (MI); On-site; USD 120,000 - 180,000; Full time

Job summary

MMS is a data-focused clinical research organization seeking a Senior Submissions Project Manager in the United States to lead IND, NDA, and MAA submissions. You will work with cross-functional teams across regulatory, clinical, biometrics, and regulatory operations to meet deadlines and ensure high-quality submissions.

You will manage budgets, timelines, risk, and client engagements, guiding teams across remote and global sites.

Qualifications

• Bachelor’s degree or equivalent relevant experience, with at least 5 years of project coordination, project management, or related experience.
• Expert knowledge of pharmaceutical development phases and NDA structure; NDA and MAA filing experience strongly preferred.
• Demonstrated experience developing and managing integrated regulatory submission plans, including timelines, dependencies, critical paths, risks, resource needs, and contingency plans.
• Strong organizational, communication, collaboration, and problem-solving skills, with the ability to understand stakeholder needs and develop practical solutions.
• Experience managing project budgets, invoicing, profitability, margins, and utilization, with the ability to analyze financial performance and take appropriate action.

Responsibilities

• Lead the planning and preparation of IND, NDA, and MAA submissions to applicable regulatory authorities in partnership with functional leads
• Partner with cross-functional clinical, biometrics, regulatory writing, regulatory affairs, and regulatory operations teams to identify dependencies, mitigate risks, and adjust operational strategies to meet submission deadlines
• Develop and maintain detailed submission timelines, including dependencies, critical paths, resource needs, and contingency plans for critical tasks
• Oversee multiple client engagements and concurrent deliverables, prioritizing a high-volume, complex workload to meet submission deadlines
• Lead project discussions, build team consensus, track progress, and provide clear project metrics and status, risk, and performance updates to key stakeholders
• Manage project budgets, revenue recognition, timely invoicing, profitability, margins and utilization
• Contribute to RFP scoping and costing efforts and clearly communicate the company’s value proposition in written and verbal business development discussions
• Partner with clients to understand their needs, evaluate options, and recommend practical business solutions
• Identify opportunities to improve customer satisfaction and strengthen long-term client relationships
• Facilitate effective meetings with remote and global teams, communicate changes clearly, negotiate constructively, resolve conflicts, and promote efficient collaboration
• Support continuous improvement by identifying opportunities to enhance project processes, collaboration, and outcomes
• Promote open communication and effective collaboration across remote and global teams

Skills

Regulatory submissions

Project management

Cross-functional leadership

Budget management

Stakeholder communication

Remote/global teams

Education

Bachelor's degree

Job description

MMS is a data-focused clinical research organization seeking a Senior Submissions Project Manager in the United States to lead IND, NDA, and MAA submissions. You will work with cross-functional teams across regulatory, clinical, biometrics, and regulatory operations to meet deadlines and ensure high-quality submissions.

You will manage budgets, timelines, risk, and client engagements, guiding teams across remote and global sites.