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, as well as input into the global regulatory strategy and regional requirements for new products and indications.

Key responsibilities

• Provide direction for regulatory activities for products and projects in the Immunology therapeutic area and work with head-office liaisons and local operating companies to 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 submission strategy, label and TPP, and core data sheets, and advise on health authority meetings
• Support product variations, labeling changes, supplements and amendments, and respond to health authority inquiries
• Lead regulatory submissions, including lifecycle submissions, and track approval milestones and post-approval commitments
• Act as primary contact with regional teams such as commercial, market access, supply chain, legal and patent, and lead regulatory activities on cross-functional teams
• Oversee regional regulatory staff and support talent development
• Manage regional in-licensed registration submissions and join 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 in the region
• 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