APAC Regulatory Affairs Leader - Strategy & Execution

Takeda Pharmaceuticals (Asia Pacific) Pte Ltd; Singapore; On-site; SGD 320,000 - 600,000; Full time

Job summary

Takeda Pharmaceuticals (Asia Pacific) Pte Ltd seeks the Regional Head Regulatory Affairs, APAC to provide strategic leadership across APAC, guiding local and international teams to align with global regulatory strategy and ensure timely registrations and lifecycle management.

This senior role partners with business leaders and authorities to shape regulatory strategy, drive harmonization, strengthen compliance, and enable patient access while building a high-performing organization.

Qualifications

• Advanced degree (PhD, PharmD, MD, MSc) in life sciences or pharmacy.
• 15+ years of progressive Regulatory Affairs experience in pharma/APAC.
• 8–10+ years of leadership experience across multi-country teams.
• Extensive expertise in APAC regulatory affairs.
• Senior-leadership training and people management experience.
• Continuous professional development in regulatory rules and guidelines.
• Proven engagement with national authorities and regulatory strategy.
• Experience leading through matrix organizations and change.
• Enterprise leadership, strategic thinking and influencing at senior levels.
• Strong stakeholder management, communication, and executive presence.
• Ability to build, align and inspire high-performing teams across geographies.
• Deep understanding of evolving EU regulatory landscape.
• Excellent written and spoken English; APAC languages an advantage.

Responsibilities

• Provide strategic and operational leadership to APAC RA networks.
• Define and execute regulatory strategies for drug development in APAC.
• Represent APAC in regulatory strategy forums and regional governance.
• Oversee lifecycle management: submissions, variations, renewals, labeling.
• Ensure compliance and audit readiness across APAC.
• Partner with cross-functional teams to enable product launches.
• Drive regulatory intelligence and anticipate changes.
• Develop and retain regulatory talent across APAC.
• Plan APAC RA budget and resources.
• Establish governance and reporting for APAC RA.
• Sponsor regional transformation and operating-model initiatives.
• Represent Takeda in external regulatory initiatives.
• Ensure values and ethics compliance across APAC.

Skills

Executive presence

Stakeholder management

Strategic leadership

Regulatory affairs

Education

Advanced degree (PhD, PharmD, MD, MSc)

Job description

Takeda Pharmaceuticals (Asia Pacific) Pte Ltd seeks the Regional Head Regulatory Affairs, APAC to provide strategic leadership across APAC, guiding local and international teams to align with global regulatory strategy and ensure timely registrations and lifecycle management.

This senior role partners with business leaders and authorities to shape regulatory strategy, drive harmonization, strengthen compliance, and enable patient access while building a high-performing organization.