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 leadership for the local regulatory affairs department in Asia Pacific, implementing regional and local regulatory strategy for products and projects.

Key responsibilities

• Provide strategic leadership for the local regulatory affairs department in Asia Pacific and implement regional and local regulatory strategy for products and projects
• Give region or country input into the global regulatory strategy, including regional requirements for regulatory filings and the placement of clinical trials
• Lead portfolio review of early portfolio assets before pivotal Phase 3 studies and prepare for health authority meetings
• Oversee product variations such as labeling changes, supplements and amendments, and respond to health authority inquiries
• Support affiliates in the region and act as the main contact with local operating companies and regional functions
• Manage regulatory submissions, including lifecycle submissions, and track approval milestones
• Provide people management and coaching for regional regulatory staff

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, labeling requirements and dossier components
• Knowledge of health authority structures and interaction strategies
• Awareness of pricing and reimbursement issues in Asia Pacific