Senior Director, Global Regulatory Strategy

Hengrui USA; New Jersey; Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401k with company match

Life Insurance

Voluntary benefits

Job summary

Hengrui USA is seeking a Senior Director of Global Regulatory Affairs to lead regulatory strategy for innovative products across indications and guide global submissions through NDA, BLA, and MAA processes. You will manage regulatory activities with global teams and interface with health authorities to align development plans with registration objectives.

The role requires overseeing regulatory risk management, lifecycle planning, and complex program leadership, including interactions with FDA

Qualifications

• Proven track record in preparation and submission of MAAs/BLAs, INDs/IMPDs, or equivalent, including lifecycle management.
• Strong knowledge of global regulatory requirements and guidelines (ICH, FDA, EMA).
• Demonstrated ability to develop and execute global regulatory strategies and support health authority interactions.
• Experience contributing to regulatory submissions, briefing documents, and responses to health authority queries.
• Strong strategic thinking, collaboration, and ability to influence cross-functional teams.

Responsibilities

• Coordinate regulatory staff and resources across portfolio products for multiple indications.
• Provide strategic oversight from early development through to registration and expansion.
• Oversee regulatory activities across clinical, CMC, and manufacturing with cross-functional teams.
• Identify and mitigate regulatory risks across CMC, clinical, nonclinical and pharmacology.
• Engage with health authorities, lead or support regulatory meetings and communications.

Skills

Global regulatory strategy

FDA/EMA experience

Cross-functional leadership

Regulatory submissions

Risk assessment

Lifecycle management

Education

PhD in life sciences or related field

Job description

Hengrui USA is seeking a Senior Director of Global Regulatory Affairs to lead regulatory strategy for innovative products across indications and guide global submissions through NDA, BLA, and MAA processes. You will manage regulatory activities with global teams and interface with health authorities to align development plans with registration objectives.

The role requires overseeing regulatory risk management, lifecycle planning, and complex program leadership, including interactions with FDA