Director, APAC Regulatory Affairs, Immunology

About the role

The Regulatory Affairs Director is a member of the Global Regulatory Affairs organization and serves as the regulatory regional office for the Immunology portfolio, reporting to the therapeutic immunology head. The role covers leadership of Nipocalimab and the early portfolio, and provides strategic input to the local regulatory affairs department in Asia Pacific, including the opportunity to place clinical trials in the region.

Key responsibilities

• Provide direction for regulatory activities for Immunology products and projects, working with head-office liaisons and local operating companies to define and implement regional and local strategy
• Manage multi-national regulatory and lifecycle strategies, and expedite approvals of new products, indications and line extensions
• Guide local affiliates on submissions, including label and TPP input, and advise on core data sheets
• Lead health authority interactions, including preparing for and presenting at meetings, and respond to HA inquiries
• Review and support critical submission documents, track milestones and post-approval commitments, and lead regional cross-functional teams
• Oversee product variations such as labeling changes, supplements and amendments, and support affiliates in the region
• Provide people management and coaching for regional regulatory staff, and act as a member of the Asia-Pacific leadership team

Required profile

• Reports to the Senior Director, Regional Regulatory Immunology Head, with direct line supervisory responsibility
• Works independently in a complex environment with very limited managerial oversight
• Required leadership competencies: applied technical knowledge, business acumen, decision making, external focus, leading and influencing, and persuasive communication

Required skills

• Detailed knowledge of local laws, regulations and guidance covering the full drug life cycle
• Understanding of drug development, CMC, clinical and non-clinical data, and pricing and reimbursement issues in Asia Pacific
• Detailed knowledge of Health Authority structures and submission requirements, including labeling
• Line management and mentoring skills