Global Regulatory PM Director - Submissions & Strategy

BeiGene, Ltd.; Northern (KY); Hybrid; USD 147,000 - 197,000; Full time

Benefits offered by this job

Equity awards

Employee Stock Purchase Plan

Comprehensive benefits package

Wellness program

Paid Time Off

Job summary

BeOne Medicines Ltd. seeks an Associate Director, Global Regulatory Project Management to lead regulatory strategies and submissions across the global development lifecycle. You will partner with GRL/RRL, drive cross‑regional projects, and ensure timely regulatory deliverables.

The role requires 8+ years in regulatory PM, with experience across IND/CTA and NDA/BLA/MAA, plus strong leadership and stakeholder skills in a global context. Travel may be required as projects demand.

Qualifications

• Bachelor’s degree in Science or related discipline; advanced degree preferred.
• Minimum 8+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with global exposure.
• PMP or similar certification preferred.

Responsibilities

• Translate, implement, and advise on global regulatory strategies across major regions.
• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across regions.
• Organize cross-functional meetings to coordinate submission activities and manage timelines across time zones.

Skills

Regulatory leadership

Project management

Global collaboration

Strategic thinking

Cross-functional leadership

Stakeholder management

Data analysis

Education

Bachelor’s degree in Science or related discipline

Advanced degree preferred

Tools

Smartsheets

MS Project

Power BI

MS Office suite

Job description

BeOne Medicines Ltd. seeks an Associate Director, Global Regulatory Project Management to lead regulatory strategies and submissions across the global development lifecycle. You will partner with GRL/RRL, drive cross‑regional projects, and ensure timely regulatory deliverables.

The role requires 8+ years in regulatory PM, with experience across IND/CTA and NDA/BLA/MAA, plus strong leadership and stakeholder skills in a global context. Travel may be required as projects demand.