Title:  Associate Director, Medical Affairs

Associate Director, Regulatory Affairs

About the Role

Every product that reaches a patient or an animal in need begins with a regulatory decision — and as Associate Director, Regulatory Affairs at DKSH, you are the leader who makes that possible, steering a dedicated team of regulatory professionals with strategic vision, uncompromising integrity, and genuine passion for improving lives. This role stands at the intersection of science, law, and business, serving as the trusted regulatory authority and indispensable strategic partner that keeps DKSH's healthcare portfolio compliant, competitive, and continuously growing across Thailand.

What You Will Deliver

• Lead, inspire, and develop a high-performing Regulatory Affairs (RA) team of direct and indirect reports, building a culture of accountability, integrity, continuous learning, and shared ownership for regulatory excellence.
• Define and drive the strategic direction for Regulatory Affairs, ensuring the function is proactively aligned with business priorities, client commitments, and Thailand's evolving regulatory landscape.
• Serve as a trusted and strategic business partner to internal and external stakeholders, translating complex regulatory requirements into clear, actionable guidance that enables timely market access and business continuity.
• Champion regulatory compliance across the entire healthcare portfolio, ensuring all activities are conducted with the highest standards of accuracy, ethics, and alignment with Thai Food and Drug Administration (Thai FDA) regulations and applicable laws.
• Oversee the timely and successful registration of healthcare products and product variations, holding the team accountable to defined Key Performance Indicators (KPIs), client timelines, and regulatory service agreement commitments.
• Build and sustain authoritative relationships with government agencies, regulatory authorities, industry associations, and networks, representing DKSH's interests with credibility and confidence, and negotiation capability.
• Lead proactive regulatory risk analysis and risk management, anticipating compliance challenges and delivering solutions that protect business operations, clients, and ultimately, patients and animals.
• Translate international guidelines and ASEAN regulatory developments into actionable intelligence that keeps DKSH's business ahead of regulatory change and positions the organization as a leader in the field.
• Provide the highest level of regulatory advice and recommendations to executive leadership, supporting informed governance decisions and ensuring full organizational awareness of regulatory developments.
• Oversee the development and continuous improvement of Standard Operating Procedures (SOPs), work instructions (WIs), and supporting documentation for Regulatory Affairs, pharmacovigilance (PV), and related functions.
• Collaborate with regional teams and principals to deliver new regulatory projects on time, navigating competing priorities and tight client deadlines with decisiveness and clarity.
• Administrative duties and coordination tasks as required.

What You Bring

• Bachelor's Degree in Pharmacy, Science, or a related health product field.
• Minimum 10 years of progressive experience in Regulatory Affairs, with demonstrated leadership responsibility and a strong record of regulatory impact across complex, multi-product portfolios.
• Deep expertise in Thai FDA regulations, pharmaceutical registration processes, and product compliance frameworks, with the confidence to navigate unclear or evolving regulatory requirements.
• Strategic Agility: You read the regulatory landscape ahead of change, translating emerging guidelines and ASEAN developments into strategies that protect the business and advance the portfolio.
• Decision Making: You make sound, confident decisions in high-stakes regulatory situations, balancing risk, compliance requirements, and business impact with clarity and accountability.
• Leadership: You lead with purpose, inspiring a large, diverse regulatory team to perform at their best by creating an environment of trust, high standards, and shared ownership for results.
• Communication: You communicate complex regulatory matters with authority and clarity to government authorities, clients, and senior leadership in both Thai and English, and you listen actively to build alignment and trust.
• Customer and Client Orientation: You understand your clients' business deeply, delivering regulatory solutions that build lasting partnerships and position DKSH as an indispensable partner in their success.
• Commitment and Integrity: You are the guardian of regulatory integrity, holding yourself and your team to the highest ethical standards in every decision, every submission, and every interaction.
• Passion and Positive Attitude: You bring genuine purpose and energy to this role, motivated by the meaningful difference that compliant, approved products make in the lives of patients and animals.
• Adaptability and Authenticity: You navigate complexity and ambiguity with composure, leading authentically to earn the trust of your team, your clients, and your business partners.
• Strong problem-solving capability and pragmatic mindset, with the ability to clarify and execute actions even when regulatory guidance is ambiguous or incomplete.
• Proven project management and time management skills, enabling consistent delivery across a large and demanding portfolio of clients, products, and regulatory obligations.

Why Join DKSH

At DKSH, we help companies grow in Asia and enable people to perform at their best. You will be part of an organization that values accountability, collaboration, and long-term partnerships. We offer a dynamic environment where your contributions are visible and where you can build a meaningful career in Regulatory Services.