Mauli Shah

Regulatory Project Manager @Freyr Solutions

Toronto, ON, CA

Leading cross functional submission working groups (SWG) to deliver successful submissions/filings and outcomes to HealthAuthorities across the globe by providing expert and effective Project Management leadership, oversight, direction and planning.• Partnering with the program Global Reg Lead (GRL) to co-lead and facilitate Global Reg meetings and cross-functionalsubmission working groups (SWG) meetings for submissions to Health authorities including (FDA, Health Canada,EMA)• Overseeing, planning and delivering Global Regulatory goals and regulatory submissions in accordance with regulatorystrategy of the program.• Developing and maintaining integrated regulatory project plans and timelines• Preparing reports and metrics on major regulatory milestone status, collaborating with the GRL in presenting operational strategiesand plan statuses to key stakeholders• Identifying and escalating high impact business critical issues and potential critical issues. Designing a proposed plan of action, asappropriate, in a timely manner to GRL and management.• Developing process flows for internal processes and training new incoming regulatory colleagues on these processes.

Northeastern University

Master of Science (MS), Pharmacy Administration and Pharmacy Policy and Regulatory Affairs

Pune University

Bachelor of Pharmacy - BPharm

Goldey-Beacom College

Master of Business Administration - MBA, Health/Health Care Administration/Management