Director, Global Regulatory Strategy (Remote/Hybrid)

Hengrui USA; United States; Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, vision

401k with company match

Life Insurance

Paid time off

Job summary

Hengrui USA is seeking a Director of Global Regulatory Affairs to lead regulatory strategies for innovative programs. This role partners with cross-functional teams to develop plans for NDA/BLA/MAA submissions and global lifecycle management, driving alignment with development and manufacturing readiness.

The position requires experience shaping regulatory strategies across multiple authorities, mentoring staff, and delivering in a fast-paced, global environment with hybrid/remote flexibility.

Qualifications

• Experience preparing MAAs/BLAs/INDs and lifecycle management.
• Global regulatory strategy development and health authority interactions.
• Experience with regulatory submissions and responses to queries.
• Strong cross-functional collaboration and influence.

Responsibilities

• Coordinate resourcing and mentor team across portfolio products.
• Provide strategic regulatory oversight from early development to registration and expansion.
• Collaborate with cross-functional teams on regulatory plans and health authority interactions.
• Lead or support FDA/health authority meetings and communications.
• Monitor evolving regulatory requirements and advise on compliance.
• Manage direct reports and performance.
• Develop global regulatory strategies and risk assessments.

Skills

Regulatory strategy

Cross-functional leadership

FDA/EMA knowledge

Project management

Communication skills

Education

PharmD or PhD

Life sciences background

Job description

Hengrui USA is seeking a Director of Global Regulatory Affairs to lead regulatory strategies for innovative programs. This role partners with cross-functional teams to develop plans for NDA/BLA/MAA submissions and global lifecycle management, driving alignment with development and manufacturing readiness.

The position requires experience shaping regulatory strategies across multiple authorities, mentoring staff, and delivering in a fast-paced, global environment with hybrid/remote flexibility.