Responsibilities
- Offer regulatory advice and support on compliance and regulatory activities in the ASEAN region, including assistance with commercial and technical inquiries.
- Develop and maintain key relationships with regulatory bodies (government agencies, associations, local distributors, third-party manufacturers) to ensure smooth compliance and approval processes.
- Provide regulatory guidance to the supply chain regarding third-party warehouse activities and manage any regulatory impacts.
- Prepare and supply regulatory documents to support group regulatory needs (e.g., free sale certificates, letters of authorization).
- Assist current manufacturers and explore potential new manufacturing partnerships in the region.
- Review all labelling and related documentation (e.g., safety data sheets) to ensure compliance with statutory requirements.
- Coordinate and support product registration activities.
- Report regulatory activities to relevant stakeholders and the Global Regulatory Affairs Manager on a weekly basis.
Business Support:
- Address local and Group business development queries.
- Investigate potential business partnerships with stakeholders for R&D projects within the Group.
- Train new staff on regulatory constraints and challenges.
- Explore and implement new technologies, ideas, and innovations relevant to company and customer requirements (e.g., regulatory processes, databases, forms).
Requirements:
- A minimum of 5 years of experience in regulatory affairs or Compliance, with a focus on the ASEAN region.
- Proven experience in dealing with regulatory bodies and managing product registrations in the ASEAN countries.
- Ability to establish and maintain effective relationships with regulatory bodies, industry associations, and other stakeholders.
- Strong organizational and project management skills, with the ability to handle multiple tasks and projects simultaneously.
- Attention to detail and a high level of accuracy in reviewing and preparing regulatory documentation.
