Project Manager II, Regulatory Submissions (Remote - US) Project Management

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

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Core 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.

Requirements

• Bachelor's degree or equivalent relevant experience, with at least 5years 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.
• Demonstrated ability to manage multiple client engagements and concurrent deliverables while prioritizing a high-volume, complex workload.
• Demonstrated experience leading client-facing discussions and collaborating effectively with remote, global, and cross-functional teams.
• Working knowledge of CRO operations and the drug development process.