RA Substances CoE AP Regulatory Affairs Lead
Location: KL, MYS
Function: Global Regulatory Affairs – Substance & Material Center of Excellence (CoE)
Reports to: Global Substance & Material CoE Lead
About the Role
Lead and manage regulatory affairs activities for substances, polymers, and biocide actives across the Asia Pacific region with a strong focus on Korea and key regional markets including Philippines, Vietnam, Thailand, Australia, and New Zealand as member of a global team.
Responsibilities
- Lead substance, biocide active and polymer registrations across AP, ensuring compliance with local regulatory frameworks
- Manage and oversees dossier preparation, data sharing activities and submission, testing strategies and study management, data gap analysis and risk mitigation
- Develop and execute regulatory strategies and advocacy related to substances, engaging with authorities and industry associations
- Act as AP lead within the Substance CoE, aligning regional execution with global processes and coordinating stakeholders
- Monitor and interpret regulatory developments across APAC markets
- Translate regulatory changes into clear business impact assessments and action plans
- Act as a strategic regulatory partner to business and innovation teams. Support key customer projects and strategic accounts through regulatory expertise
- Lead or co-lead global digital projects, e.g. AI initiatives and data sharing frameworks
- Coordinate with Regional regulatory teams, Toxicology, Product Safety, and data experts within the CoE, External partners, test laboratories, and consultants
Qualifications
- Master's / PhD in Chemistry, Toxicology, Regulatory Affairs, or related field
- 5+ years of regulatory affairs experience (chemical focus)
- Experience in regulatory advocacy and authority interaction
- Strong strategic thinking and business acumen
- Excellent stakeholder management across global teams
- Advanced project and program management skills
- Ability to operate in a matrixed, global organization
- Korean language skills would be a plus
