Senior Director, Global Regulatory Affairs

Job Title:

Senior Director, Global Regulatory Affairs Reports to (Title): VP, Hengrui USA

Location:

Hybrid for NJ/MA candidates & Remote for out-of-state

Job Summary:

The Senior Director of Global Regulatory Affairs is responsible for developing and implementing regulatory strategies for assigned products, with the goal of successfully developing, filing, and registering innovative and technologically complex products across indications and managing their global lifecycle. The role will play a key leadership role in several upcoming NDA, BLA, and MAA submissions, providing an exceptional opportunity to lead high-impact global regulatory programs from late-stage development through regulatory review and approval.

This individual will work with assigned regulatory professionals and cross-functional teams globally to provide strategic and operational regulatory leadership, with a high sense of urgency and a strong focus on successful execution.

The individual will provide strategic regulatory oversight across clinical, nonclinical, clinical pharmacology, and CMC, ensuring integrated regulatory strategies and submission plans are aligned with product development, manufacturing readiness, and global registration objectives. The individual will also serve as a key regulatory representative in interactions with global health authorities, including FDA and EMA, and build effective and constructive relationships with internal and external stakeholders.

The responsibilities of the Senior Director include:

• Work together with the assigned team staff at various levels, coordinating resourcing and balancing project support across portfolio products developed for all indications. Provide ad hoc leadership and career development input as well as coaching/mentoring support to other team members.
• Provide strategic oversight for projects across all indications, aligned to overall R&D objectives from early development, through initial registration and as appropriate subsequent global expansion, and including implementation of new indications and formulations.
• Provide regulatory oversight across clinical, clinical pharmacology, CMC, and manufacturing activities, in collaboration with relevant cross-functional teams; assess regulatory risks and readiness and provide strategic input to development plans, submissions, health authority interactions, and product lifecycle management.
• Identify, assess, and mitigate cross-functional regulatory risks, including CMC, clinical, nonclinical, and clinical pharmacology risks, and develop proactive strategies to address potential health authority concerns and support successful global registration.
• Actively collaborate with management and cross functional colleagues (including commercial, research, clinical development, medical affairs, business development) to provide portfolio level regulatory insight and broader drug development expertise.
• Acts as a key regulatory representative in interactions with global health authorities (including FDA), leading or supporting regulatory meetings and communications as appropriate.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs. Provide support to Global Regulatory Affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
• Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies.
• Assesses the impact of new regulations, guidance or enforcements and advises the broader Regulatory Group on requirements to maintain compliance with regulatory operations activities.
• Monitors assess and maintain current awareness of evolving USA regulations and guidance documents; apprises management of the impact of these changes.
• Manages any assigned direct reports, including recruitment, training, coaching, development, assignments, coordination of workload priorities, and performance.
• Fosters collaborative, efficient, and effective working relations with internal and external colleagues to further build the cordial working relationship between Hengrui USA and overall organization.
• Lead or contribute to development of global regulatory strategies, including health authority engagement plans, briefing documents, and regulatory risk assessments
• Other activities as assigned.

• Proven track record in preparation and submission of MAAs/BLAs, INDs/IMPDs, or equivalent, including lifecycle…