Global Regulatory Affairs

Position Summary

The Global Regulatory Lead will develop and execute global regulatory strategies, lead regulatory activities for assigned oncology programs, manage global submissions, and represent Regulatory Affairs on cross-functional project teams.

Key Responsibilities

• Lead global regulatory strategy and execution for assigned programs.
• Represent Regulatory Affairs on Global Project Teams.
• Lead the Global Regulatory Sub-Team (GRST).
• Manage global regulatory submissions through approval.
• Coordinate FDA/EMA regulatory interactions and briefing documents.
• Develop regulatory strategies aligned with development plans.
• Collaborate with Regulatory Project Management and Submission Management.
• Provide matrix leadership across cross-functional teams.

Required Qualifications

• Advanced degree (MS, PhD, PharmD, MD, or equivalent).
• 6+ years of Regulatory Affairs experience.
• 3+ years of recent Oncology Regulatory experience (Required).
• Strong experience with FDA and/or EMA interactions.
• Proven experience leading global regulatory strategies.
• Excellent matrix leadership, communication, and stakeholder management skills.
• Strong written and verbal English communication.

Preferred Keywords

• Global Regulatory Affairs
• Regulatory Strategy
• Oncology
• FDA
• EMA
• IND
• NDA
• BLA
• Global Submissions
• Regulatory Project Management
• Matrix Leadership
• Health Authority Interactions