senior director, regulatory affairs apac.

The Head of Regulatory Affairs, Asia Pacific, will lead the development, implementation, and oversight of regulatory strategies across the Asia Pacific (APAC) region. This individual will ensure alignment with global business objectives while securing and maintaining market access for products in the region. The role requires close coordination with cross-functional internal stakeholders and global regulatory counterparts.

Key Responsibilities:

• Strategic Leadership:

  • Develop and implement APAC regulatory strategies for clinical development programs and marketed products, aligned with corporate and regional business goals.

  • Serve as the regional regulatory expert, advising internal teams on evolving regulatory requirements and trends within APAC markets.

• Regulatory Execution & Oversight:

  • Oversee regulatory submissions and interactions with health authorities across APAC, including INDs, NDAs/MAAs, CTAs, and post-approval variations.

  • Ensure timely and compliant delivery of regulatory milestones across all stages of product development and lifecycle.

• Team Management & Development:

  • Lead and manage a high-performing regional regulatory team across multiple APAC markets.

  • Provide mentorship, technical guidance, and career development support for regulatory professionals at varying levels.

  • Foster a culture of collaboration, continuous learning, and high ethical standards.

• Cross-Functional Collaboration:

  • Partner with Clinical, Medical Affairs, Commercial, Quality, Pharmacovigilance, and Global Regulatory teams to ensure integrated and harmonized regulatory strategies.

  • Represent APAC regulatory affairs in global project teams and governance forums.

• Compliance & Intelligence:

  • Monitor and interpret regulatory changes and emerging trends within the APAC region.

  • Ensure all activities comply with local regulatory requirements and company standards.

about the manager/team
Reports to Senior VP, Regulatory Affairs.

skills and experience required

• Minimum 12 years of experience in the biotechnology or pharmaceutical industry, with at least 8 years in a regulatory leadership capacity, specifically with a broad background in oncology.

• Proven experience within a multinational pharmaceutical or biotechnology company.

• Knowledge in Inflammation and Immunology is highly desirable.

• Demonstrated experience as a Regulatory Affairs lead across at least two major APAC markets, with a strong track record in both small molecules and biologics.

• Extensive experience conducting and leading health authority (HA) interactions, resulting in successful agency approvals.

• Strong managerial and leadership skills, with the ability to effectively collaborate across multiple functional teams.

• A history of regulatory success in the APAC region, including strategy development and execution.