Executive Regulatory Affairs

About the role

The Executive, Regulatory Affairs supports the Regulatory Affairs Lead in managing all regulatory and pharmacovigilance activities for DKSH BRN Sdn Bhd in Brunei Darussalam. The role ensures full regulatory compliance, timely submissions, and effective post‑market surveillance while providing backup support for pharmacovigilance and branding initiatives.

Key responsibilities

• Prepare and submit regulatory dossiers, SMP applications, renewals, cosmetics, foods, and THMS submissions, meeting strict deadlines.
• Respond to agency and client queries, maintain technical files, and document all communications.
• Ensure company operations comply with local laws, maintain required licenses, and author SOPs, work instructions, and policies.
• Conduct post‑market surveillance of promotional materials, labeling, batch records, and specifications.
• Participate in internal and external audits, disseminate regulatory updates, and support CAPA plans.
• Act as backup Responsible Person for Pharmacovigilance, liaising with NADRMC and MOH on safety information.
• Coordinate with client PV contacts for adverse event reporting and maintain PV logs.
• Provide backup support for branding activities and perform administrative tasks, including stock checks.

Required profile

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.

Required skills

• Regulatory submission preparation and management.
• Pharmacovigilance reporting and liaison.
• SOP and policy development.
• Post‑market surveillance and compliance review.
• Audit participation and CAPA implementation.