Regulatory Affairs Specialist

What you'll do:

• You will be responsible for preparing comprehensive dossiers and managing all aspects of product registration for medical devices, home base devices, cosmetics, and skincare products.
• Your role will involve renewing product approvals efficiently while maintaining up-to-date documentation in accordance with regulatory requirements.
• You will liaise closely with Thai FDA authorities to ensure all submissions meet local standards and regulations.
• You will monitor regulatory changes and proactively update internal teams on new requirements affecting product registrations.
• You will collaborate with cross-functional teams including marketing, sales, logistic and manufacturing to facilitate smooth product launches.
• You will provide guidance on regulatory strategies for new products and support the development of compliant labelling and packaging.
• You will maintain accurate records of all regulatory activities and ensure timely reporting to management.
• You will assist in resolving any issues related to product compliance or registration delays by communicating effectively with relevant stakeholders.
• You will contribute to the continuous improvement of internal processes related to regulatory affairs by sharing insights and best practices.

What you bring:

• Fluent in English and Thai language
• A Bachelor’s degree in Pharmacy or Life Science is essential for this position as it provides the foundational knowledge required for success.
• Proven experience in product registration specifically within the medical device, cosmetic, or skincare categories is highly valued.
• Familiarity with Thai FDA authority procedures is crucial for navigating local regulations effectively.
• The ability to work independently while also contributing positively within a team setting demonstrates your dependability.
• Excellent interpersonal skills enable you to communicate clearly with both internal teams and external authorities.
• Strong organisational abilities allow you to manage multiple projects simultaneously while maintaining attention to detail.
• A commitment to continuous learning ensures you stay updated on evolving regulatory requirements.
• Sensitivity towards compliance issues helps you identify potential risks early and address them appropriately.
• A polite and considerate approach fosters positive relationships with colleagues and stakeholders alike.

Apply today by clicking on the link provided below.