Global Regulatory Affairs

Trident Consulting is seeking a " Global Regulatory Affairs Director for one of our client in "Remote". A global leader in business and technology services.

Role: Global Regulatory Affairs Director (Global Regulatory Lead)

• Location: Remote (Must be based in the U.S.)
• Preferred Time Zone: EST
• Employment Type: Contract (40 hrs/week)
• Interview: Virtual
• Priority: High Priority Immediate Need
• Start Date: ASAP (Preferred before Sept. 17 18)
• Pay: $120/hr on w2

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