Head of Regulatory Affairs & Quality

This Role is a senior leadership position responsible for providing medical and scientific leadership The role leads the development and execution of Medical Affairs strategy across the pharmaceutical portfolio, while building strong scientific relationships with healthcare professionals, KOLs, and other external stakeholders. The position also provides oversight of Regulatory Affairs and Quality Assurance and works closely with commercial, functional, and regional teams to support product development, launches, lifecycle management, compliance, and business growth. The role serves as a key medical and scientific leader for the organization, ensuring decisions are grounded in sound science, evidence, patient needs, and ethical standards.

Key responsibilities

• Lead and oversee Medical Affairs activities , providing strategic medical and scientific leadership across the company's portfolio, including Gilead, Tolmar, and new products.
• Develop and implement the Medical Affairs strategy and annual medical plan in alignment with business priorities, patient needs, scientific evidence, and applicable regulations.
• Provide senior medical and scientific leadership to ensure the safe, appropriate, and effective use of the company's products through high-quality, non-promotional scientific engagement with Healthcare Professionals, Experts, KOLs, Advisory Board members, investigators, and other relevant stakeholders.
• Serve as the senior scientific expert for assigned therapeutic areas, maintaining strong knowledge of clinical evidence, treatment guidelines, disease areas, competitive developments, and emerging scientific data.
• Identify and develop relationships with leading experts, KOLs, investigators, professional societies, and other relevant external stakeholders, establishing credible peer-to-peer scientific relationships.
• Oversee the provision of accurate, balanced, evidence-based responses to unsolicited medical and scientific inquiries, including requests for on-label and, where permitted, off-label or unapproved information, in accordance with applicable regulations and company policies.
• Supervise and provide strategic direction to the Regulatory Affairs team to ensure timely and compliant management of product registrations, variations, renewals, regulatory submissions, and interactions with the Thai FDA and other relevant authorities.
• Supervise and provide strategic direction to the Quality Assurance team to ensure compliance with applicable GxP requirements, Thai regulations, company quality systems, and relevant industry standards.
• Provide functional leadership across Medical Affairs, Regulatory Affairs, and Quality Assurance, fostering collaboration, accountability, and a strong quality and compliance culture.
• Ensure all Medical Affairs, Regulatory Affairs, and Quality Assurance activities are conducted ethically, scientifically sound, and in compliance with applicable Thai regulations, industry codes, policies and procedures.

About you

• Bachelor's degree in Pharmacy or Medicine. A Master's degree, PharmD, MD, or PhD is a plus.
• Minimum 8–10 years of relevant experience in Medical Affairs within the pharmaceutical industry, with working knowledge or cross-functional exposure to Regulatory Affairs, Pharmacovigilance, and Quality Assurance.
• Strong understanding of the Thailand healthcare system, pharmaceutical market, regulatory environment, reimbursement landscape, and key healthcare stakeholders.
• Strong scientific and clinical knowledge, with the ability to critically assess clinical data, scientific literature, treatment guidelines, and emerging evidence.
• Proven experience in developing and executing Medical Affairs strategies, medical plans, scientific engagement plans, and stakeholder engagement activities.
• Proven experience in establishing and maintaining peer-to-peer relationships with KOLs, Healthcare Professionals, investigators, professional societies, and other external stakeholders.
• Strong ability to communicate complex scientific and clinical information clearly and effectively to both scientific and non-scientific audiences.
• Proven people leadership and team management experience, with the ability to supervise, develop, and motivate Medical Affairs and cross-functional teams.
• Strong strategic thinking, analytical, problem-solving, and decision-making skills, with the ability to balance scientific, medical, regulatory, quality, patient, and business considerations.
• Strong stakeholder management, influencing, presentation, and communication skills, with the confidence to engage effectively with senior internal and external stakeholders.
• Must be fluent in Thai and english communications

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