Global Regulatory Project Director, Oncology Submissions

BeOne Medicines USA; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

BeOne Medicines USA seeks a seasoned Director, Global Regulatory Project Management to lead global regulatory strategies across oncology programs. You will drive NDA/BLA/MAA submissions, coordinate cross-functional teams, and manage complex programs across regions including the US, EU, and APAC.

A strong leadership track record is essential. Required are 10+ years in regulatory project management with global submissions, plus a degree in science and PMP or equivalent certification.

Qualifications

• Bachelor's degree in Science or related discipline; advanced degree preferred.
• 10+ years of regulatory PM experience with global submissions (IND/CTA, NDA/BLA/MAA).
• Proven track record leading cross-regional teams and influencing senior stakeholders.

Responsibilities

• Provide strategic regulatory leadership across global development programs and major regions.
• Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions.
• Coordinate cross-functional teams and全球 regulatory authorities to expedite submissions and resolve issues.
• Identify risks and implement mitigation strategies in global regulatory timelines and processes.
• Mentor and develop junior staff in regulatory project management and processes.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic thinking

Project management

Communication

Education

Bachelor's degree in Science or related field

PMP or similar certification

Tools

Smartsheets

MS Project

Power BI

Regulatory submission platforms

Job description

BeOne Medicines USA seeks a seasoned Director, Global Regulatory Project Management to lead global regulatory strategies across oncology programs. You will drive NDA/BLA/MAA submissions, coordinate cross-functional teams, and manage complex programs across regions including the US, EU, and APAC.

A strong leadership track record is essential. Required are 10+ years in regulatory project management with global submissions, plus a degree in science and PMP or equivalent certification.