Project Manager II - Regulatory Submissions (Remote - US)

MMS; Austin (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

MMS is seeking a seasoned Regulatory Submissions Project Manager in Austin, TX to lead IND, NDA, and MAA submissions with cross-functional teams across global sites. The role emphasizes timelines, risk mitigation, and stakeholder communication to ensure timely regulatory filings.

The ideal candidate brings 5+ years in project management within pharmaceutical development, strong organizational skills, and a collaborative mindset to drive complex projects forward.

Qualifications

• Bachelor’s degree or equivalent relevant experience.
• 5+ years in project coordination or project management.
• Expert knowledge of pharmaceutical development phases and NDA/MAA structures.
• Experience developing integrated regulatory submission plans with timelines and resources.
• Strong organizational and communication skills; ability to work with remote, global teams.

Responsibilities

• Lead planning and preparation of IND, NDA, and MAA submissions with regulatory authorities.
• Partner with cross-functional teams to identify dependencies and mitigate risks.
• Develop and maintain detailed submission timelines with critical paths.
• Oversee multiple client engagements and high-volume deliverables.
• Track progress, provide metrics, and report status to stakeholders.
• Manage project budgets, invoicing, profitability, and utilization.
• Contribute to RFP scoping and communicate value proposition.
• Support client needs and recommend practical business solutions.
• Foster effective collaboration across remote and global teams.
• Identify opportunities to improve processes and outcomes.
• Promote open communication across teams.

Skills

Project coordination

Project management

Regulatory submissions

Cross-functional collaboration

Budget management

Stakeholder communication

Education

Bachelor's degree or equivalent

Regulatory affairs knowledge

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