Project Manager II, Regulatory Submissions (Remote - US)

MMS; Raleigh (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

MMS Holdings, a data-focused clinical research organization, seeks a seasoned project manager to lead regulatory submissions for INDs, NDAs, and MAAs. You will collaborate with clinical, biometrics, regulatory writing, and regulatory affairs teams to align timelines and deliverables, ensuring deadlines are met for complex programs.

The role demands strong organization, communication, and financial oversight, including budgeting and profitability.

Qualifications

• Bachelor's degree or equivalent in life sciences or related field.
• 5+ years in project coordination, project management, or related experience.
• Experience with regulatory submissions processes (IND, NDA, MAA).
• Strong organizational, communication, and problem-solving skills.

Responsibilities

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Collaborate with clinical, biometrics, regulatory writing, and regulatory operations teams to meet deadlines.
• Develop and maintain submission timelines with dependencies and critical paths.
• Manage multiple client engagements with a high-volume, complex workload.
• Provide project metrics, status updates, and risk assessments to stakeholders.
• Oversee budgets, invoicing, profitability, margins, and utilization.
• Contribute to RFP scoping and communicate the company value in business discussions.
• Engage with clients to understand needs and propose practical solutions.
• Identify opportunities to improve client satisfaction and long-term relationships.
• Facilitate meetings with remote/global teams and resolve conflicts.

Skills

Regulatory submission planning

Project coordination

Cross-functional leadership

Budget management

Stakeholder management

Regulatory affairs knowledge

Pharmaceutical development knowledge

Education

Bachelor's degree or equivalent in life sciences or related field

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 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
• 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