Regulatory Affairs Director

Regulatory Affairs Director

Reports to: Head of Medical & Regulatory Affairs, Thailand

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

DUTIES AND RESPONSIBILITIES

- Develop regulatory strategy and registration plans in liaison with Regional Regulatory Affairs, principals’ Regulatory Affairs teams, and other stakeholders, providing regulatory input and milestone plans for assigned projects in line with local business priorities, and providing support and expertise in healthcare product registration to the Business Development team in obtaining new business opportunities for regulatory services.

- Manage end-to-end product registration for drugs, medical devices, and food products under Thai FDA requirements and committed timelines, covering product classification, pre-submission, submission, responses to Thai FDA queries through to approval, new product submissions, variations, life-cycle maintenance, MAH transfers, labelling review and verification, promotional materials review and submission, and support for hospital enlisting and tendering.

- Ensure regulatory compliance with Thai FDA rules and regulations and with company and principal policies, working closely with cross-functional teams to ensure compliant product supply, smooth business operations, and the most appropriate solutions for partners.

- Register, control, and renew all company licenses required for the company as an importer and distributor, and maintain all product licenses throughout their life cycle, including import permits for special purposes of importation.

- Review and advise on promotional materials to be published under marketing and sales activities, including advertising, leaflets, and sales promotion programmes; provide, review, and work with local Legal on Registration Agreements with principals for local regulatory projects; and monitor and work with Finance to issue invoices to each principal for regulatory services fees once the agreed work has been completed.

- Provide regulatory intelligence by identifying current and emerging national regulations that impact the business, assessing their impact for the company and clients, ensuring all regulatory information and guidelines are kept up to date, reviewing new statements, and circulating updates to all relevant stakeholders.

- Safeguard quality documentation and records by ensuring that all quality-related Regulatory Affairs documentation — including labelling review and verification, second-person QC checks of submission dossiers, local-language translation and verification, and dossier maintenance activities — and records are created, revised, maintained, and destroyed in accordance with the Zuellig Pharma quality management system and documented client requirements.

- Support internal stakeholders and principals by providing regulatory expertise on request; reviewing customer questionnaires and queries and ensuring all answers meet company policy and regulations within committed timelines; and updating regulatory submission tracking records and the regional registration database and preparing monthly registration status reports for responsible products.

- Represent the company in local industry associations such as PReMA and RAPAT, playing an active role in shaping the regulatory environment and driving change, and collaborating closely with cross-functional teams and clients to provide the best and most innovative regulatory solutions as a trusted partner.

- Lead and develop the Regulatory Affairs team by building a highly effective, high-performance team, fostering a coaching and feedback culture, and driving talent management, retention, and development.

Qualification:

- Bachelor’s degree in Pharmacy required, with a Master’s degree in a related field considered an advantage.

- Minimum 15 years of experience in regulatory affairs for drugs and healthcare products, such as medical devices, food supplements, medical food, herbal products, and cosmetics.

- In-depth knowledge of Thai FDA rules and regulations, pharmaceutical and healthcare product registration requirements, and maintenance of licences, with the ability to maintain the Quality Management System across all regulatory affairs frameworks.

- Strong people management and leadership skills, with excellent interpersonal, communication, and organisational skills, and a collaborative, service-oriented approach to working with stakeholders, principals, and cross-functional teams.

- Good command of Thai and English in writing, listening, and speaking.

- Proficient in Microsoft Office applications (Word, Excel, PowerPoint); result-oriented and service-minded with a good sense of urgency and priority; well-organised, self-driven, proactive, and assertive, with strong problem-solving skills, and able to work independently and as part of a team under pressure.

What We Offer:

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.

• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.

• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.

• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.