Project Manager II, Regulatory Submissions (Remote US)

Are you looking to join a company where your contributions truly matter and where youll 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 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 companys 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

• Bachelors 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.