Regional Head Regulatory Affairs - APAC

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The Regional Head Regulatory Affairs, APAC provides strategic leadership for the Regulatory Affairs organization across APAC, leading LOC Regulatory Affairs Heads and International Regulatory Leads to ensure a unified regional voice and effective execution of global regulatory strategy.

The role shapes and drives APAC regulatory strategy, accelerating patient access, enabling successful registration and lifecycle management, and ensuring regulatory compliance. Working closely with global, regional and local stakeholders, the Regional Head brings APAC affiliate and health authority perspectives into enterprise decision-making and translates strategic priorities into consistent regional execution.

As a senior member of the International Regulatory Affairs Leadership Team, the role builds a high-performing, forward-looking organization aligned with Takeda’s business and portfolio objectives, Takeda-ism and the Patient-Trust-Reputation-Business principles.

• Provide strategic and operational leadership to the APAC Regulatory Affairs affiliate network (LOC / groups Heads RA and their teams) – setting direction, goals and standards and ensuring optimal performance and professional development.

• Accountable for regulatory strategic proposal and tactical leadership (including implementation) for drug development projects in responsible Area, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives and timelines in collaboration with  International Regulatory Leads (IRL) supporting APAC region  team and relevant stakeholders.

• Define, shape, align and ensure execution of the APAC regulatory strategy in line with the global Regulatory Affairs strategy, ensuring a single, harmonized regulatory voice across all APAC affiliates,

• Represent the APAC Regulatory Affairs in regional and global regulatory strategy forums; ensuring the regional perspective to enterprise regulatory strategy is considered regarding portfolio prioritization and operating-model decisions (“voice in regional strategy”).

• Ensure a single, consistent regulatory voice for APAC within global regulatory affairs in close partnership with the Therapeutic Area Units and Marketed Product Development

• Build and maintain effective & strategic relationships with the national competent authorities, and industry associations.

• Drive harmonization of ways of working, roles and responsibilities, processes and quality standards across the APAC RA organization in alignment with International Regulatory Affairs ways of working..

• Provide oversight of regulatory lifecycle management delivered through the affiliates across the APAC portfolio – marketing authorization applications, variations, renewals, labeling and product information – ensuring timeliness, quality and compliance.

• Ensure regulatory compliance across the region and maintain audit and inspection readiness in accordance with national legislation and internal guidelines.

• Partner with APAC business leadership, Medical Affairs, Market Access, MCE, Pharmacovigilance, Quality and Supply Chain  & partners ( where relevant) to enable successful product launches, life-cycle management and patient access, aligned with commercial priorities.

• Lead regional regulatory intelligence: anticipate and assess changes in the APAC regulatory environment and translate implications into progressive regulatory strategies, risk mitigation plans and business recommendations.

• Attract, develop and retain regulatory talent; build capability, succession and engagement across the APAC affiliate RA organization and International Regulatory Leads (IRL) supporting APAC region.

• Plan and manage the APAC affiliate Regulatory Affairs budget and resources in coordination with Finance and functional leadership.

• Establish governance, key performance indicators and reporting for the APAC RA organization, reporting into the International Regulatory Affairs Leadership Team.

Regional & enterprise leadership

• Serve as a member of the International Regulatory Affairs Leadership Team and act as senior escalation point for significant regulatory risks and issues arising in APAC.

• Serve as the central point of regulatory contract for the commercial  Area

• Sponsor and lead regional regulatory transformation and operating-model initiatives (e.g., LOC integration and harmonization of the APC RA model).

• Represent Takeda in relevant APAC and cross-industry regulatory initiatives and external engagements.

• Ensure the APAC affiliate & IRL organization operates in compliance with Takeda’s values, and all applicable ethics and compliance requirements.

• Advanced degree (PhD, PharmD, MD, MSc or equivalent) in pharmacy, life / natural sciences, medicine or a related discipline.
• 15+ years of progressive Regulatory Affairs experience in the pharmaceutical / biopharmaceutical industry, including substantial experience in the APAC environment.
• 8–10+ years of leadership experience managing multi-country or regional teams, ideally across affiliate / LOC organizations.
• Extensive expertise in APAC  regulatory affairs .

• Proven senior-leadership training and experience in people and organizational management.

• Continuous professional development in  regulatory affairs, legislation and internal guidelines.
• Demonstrated track record of engagement with national competent authorities and of contributing to regional / global regulatory strategy.
• Experience leading through a matrix and driving change across a complex, multi-cultural organization.
• Enterprise leadership, strategic thinking and the ability to influence at senior levels internally and externally.

• Strong stakeholder management, communication and executive presence.

• Ability to build, align and inspire high-performing teams across cultures and geographies.

• Deep understanding of the evolving EU regulatory landscape and its business implications.

• Excellent written and spoken English; additional APAC languages an advantage.