Global Regulatory Strategy Director, Oncology Partnerships

BeiGene, Ltd.; Northern (KY); Hybrid; USD 211,000 - 281,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. seeks a seasoned Regulatory Affairs Lead to drive global regulatory strategies for development programs in oncology. You will oversee regulatory aspects from preclinical through lifecycle management, coordinating with advisory committees and execution units to ensure compliant, timely submissions.

Required: 12+ years in biotech/pharma, 5+ years in leadership, and extensive FDA interactions. Travel up to 20% and strong collaboration across geographies are essential.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Minimum 12 years in biotech/pharma with 5+ years in regulatory leadership.
• Experience leading regulatory programs across multiple geographies (US, EU, Asia).

Responsibilities

• Provide high-level regulatory direction for development programs across phases.
• Lead preparation and submission of IND/CTA, NDA/MAA across global markets.
• Interface with Health Authorities to expedite approvals and manage issues.
• Mentor Execution Unit and ensure study planning aligns with regulatory strategy.
• Develop and implement regulatory processes and risk assessments.

Skills

Regulatory leadership

Global regulatory strategy

Regulatory submissions

FDA interactions

Oncology knowledge

Education

Bachelor’s degree

Advanced degree preferred

Tools

Microsoft Office

Job description

BeOne Medicines Ltd. seeks a seasoned Regulatory Affairs Lead to drive global regulatory strategies for development programs in oncology. You will oversee regulatory aspects from preclinical through lifecycle management, coordinating with advisory committees and execution units to ensure compliant, timely submissions.

Required: 12+ years in biotech/pharma, 5+ years in leadership, and extensive FDA interactions. Travel up to 20% and strong collaboration across geographies are essential.