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.
Responsibilities
- 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