Project Manager II - Regulatory Submissions (Remote - US)

MMS; Austin (TX); Remote; USD 120,000 - 160,000; Full time

Job summary

MMS Holdings Inc in Austin, TX is seeking a Regulatory Submissions Project Manager to lead IND, NDA, and MAA submissions with functional partners. You will coordinate cross-functional clinical, biometrics, regulatory writing, and regulatory operations teams to meet tight deadlines.

The role requires a bachelor’s degree and at least five years in project coordination or management, plus strong organization, communication, and budget stewardship.

Qualifications

• Bachelor’s degree or equivalent; at least 5 years in project coordination or PM.
• Expert knowledge of pharmaceutical development phases and NDA/MAA filing.
• Experience developing and managing integrated regulatory submission plans.
• Strong organizational, communication, collaboration and problem-solving skills.
• Experience managing project budgets, invoicing, profitability and utilization.

Responsibilities

• Lead the planning and preparation of IND, NDA, and MAA submissions with functional leads.
• Partner with cross-functional teams to identify dependencies and adjust strategies to meet deadlines.
• Develop and maintain detailed submission timelines with critical paths and resources.
• Oversee multiple client engagements and prioritize a high-volume, complex workload.
• Lead project discussions, track progress, and provide status updates to stakeholders.
• Manage project budgets, revenue recognition, invoicing, profitability, and utilization.
• Contribute to RFP scoping and communicate the value proposition in business discussions.
• Partner with clients to understand needs and propose practical solutions.
• Identify opportunities to improve client satisfaction and relationships.
• Facilitate effective meetings with remote and global teams.
• Support continuous improvement of project processes and collaboration.
• Promote open communication across remote and global teams.

Skills

Regulatory submissions

Cross-functional collaboration

Budget management

Project coordination

Regulatory affairs

Communication skills

Education

Bachelor’s degree or equivalent

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.