Regulatory Senior Project Manager

About Worldwide Research and Development

• Developing first-in-class and best-in-class therapeutics
• Engage in all bench and clinical research and supporting groups
• Work on projects related to Global Regulatory Affairs & Patient Safety (GRAPS)

Responsibilities

• Contribute to and support global regulatory strategies and operations
• Track and drive for action item completion
• Partner with GRL and functional regulatory leads to prioritize team activities
• Develop regulatory project timelines in collaboration with functional regulatory leads and cross-functional stakeholders
• Liaise with Project Managers in other functional areas to ensure regulatory timelines are integrated and linked to reflect cross-functional dependencies
• Document regulatory milestones/deliverables in the timeline(s) and report progress against team, department and corporate goals as needed
• Track regulatory submissions and approvals globally in the designated tracking system
• Monitor completion of commitments for duration of lifecycle maintenance and ensure timely status updates are made in the designated tracking system
• Enforce guidelines of GRT Charter (or other relevant team charters)
• Schedule GRT meetings, generate the agenda and facilitate the meeting
• Provide high-level support to MA/IND/CTA Filing teams
• Document decisions and/or action items for other meetings
• Liaise across regulatory teams, sub-teams, and cross-functional Filing Teams to ensure consistent communication and alignment
• Communicate regulatory information and activities to stakeholders outside of regulatory and externally
• Represent Regulatory on Production Integration Management Team (PRIME) and align on deliverables/timeline with cross-functional PMs
• Identify and implement opportunities for process improvement within GRAPS

Qualifications

• Education: Degree in health or life sciences, including chemistry, molecular biology, or similar; Masters or MBA preferred
• Experience: 6+ years with Masters/MBA, 8+ with bachelor’s degree
• Experience: Project Management in a Biotech or Pharmaceutical Company