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. It is open to applicants in Beijing, Chiyoda Tokyo and Singapore.

Key responsibilities

• Define and implement regional and local regulatory strategy for Immunology products, working with head-office liaisons and local operating companies
• Manage multi-national regulatory and lifecycle strategies, and expedite approvals of new products, indications and line extensions
• Provide technical guidance to affiliates on submissions, label and TPP, and advise on core data sheets
• Prepare for and present to health authorities, and act as primary contact with regional teams such as marketing, market access, supply chain, legal and patent
• Support product variations, labeling changes, supplements and amendments, and respond to health authority inquiries
• Review early portfolio assets before pivotal Phase 3 studies and oversee regional post-approval commitments
• Lead regional regulatory staff and mentor talent
• Manage in-licensed registration submissions and update HQ on regional regulatory changes

Required profile

• Reports to the Senior Director, Regional Regulatory Immunology Head, with direct line supervisory responsibility
• Strong leadership, decision-making and communication skills, with autonomy in a complex environment
• Understanding of the pharmaceutical industry, drug development and the regulatory environment of the region

Required skills

• Detailed knowledge of local laws, regulations and guidance covering the full drug life cycle
• Knowledge of health authority structures and submission requirements, including labeling
• Competency model covering regulatory strategy, business acumen, decision making, external focus, leading and influencing, and persuasive communication