Manager, APAC Regulatory Affairs – Oncology

About the role

The Manager, APAC Regulatory Affairs – Oncology is part of Johnson & Johnson’s Global Regulatory Affairs organization, responsible for shaping and executing the regional regulatory strategy for oncology products across the Asia‑Pacific region.

Key responsibilities

• Define and implement regional and local regulatory strategies for assigned oncology products in collaboration with global teams and local affiliates.
• Provide strategic input to global regulatory plans, identify regional requirements, and support successful filings for new products and indications.
• Manage product variations, labeling changes, supplements, amendments, and license renewals throughout the region.
• Serve as primary contact for health‑authority enquiries and coordinate responses for regional affiliates.
• Lead interactions with manufacturing sites to ensure appropriate export packaging components for product registration.
• Maintain regulatory intelligence on country‑specific requirements and communicate updates to regional management.
• Participate in preparation for health‑authority meetings and, when required, present to authorities.