Regulatory Project Manager

Salary $$60 an hour
Employment type Contract

Job description

Title: Regulatory Project Manager
Status: 6 month contract Part time 15-20 hours a week
Hourly rate: $60
Location: Remote with light travel

This candidate will support the execution of regulatory strategies within the Global Regulatory Affairs function.  Translate global regulatory strategies into submission plans, and driving the pipeline.
  • Partner with Regulatory leads to manage regulatory filing subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities.
  • Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
  • Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
  • Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
  • Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are fully informed and knowledgeable of activities, progress / delays, and risks / issues
  • Facilitate regulatory filing team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required)
  • Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices
  • Bachelor’s or higher degree in a related field with >3-4 years of experience in regulatory project management, (bio)pharmaceutical project management, and/or related discipline
  • Working knowledge of global regulatory agency regulations, guidelines, and submissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development
  • Direct hands on experience managing original Marketing Applications and/or LCM submissions from creation to submission through approval / post-approval
  • Exceptional project management and organizational skills are required, with demonstrated ability to prioritize and manage multiple tasks and projects to achieve program and department goals under tight timelines in a cross-functional environment that values both speed and quality
  • Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution and global process improvement and optimization and passion for novel project management tool building
  • Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path; direct experience with OnePager and Veeva Vault RIM is a plus