About the Role
The Executive, Regulatory Affairs supports the Regulatory Affairs Lead in managing all regulatory affairs and pharmacovigilance matters for DKSH BRN Sdn Bhd in Brunei Darussalam. This role is integral to ensuring full regulatory compliance, timely submissions, and effective post-market surveillance, while also providing backup support for pharmacovigilance and branding activities.
What You Will Deliver
- Assist with the preparation and submission of regulatory documentation including dossiers, Special Medical Product (SMP) applications, renewals, cosmetics, foods, and Traditional Health Medicine Supplement (THMS) submissions, ensuring all variations and renewals are completed accurately within strict deadlines
- Prepare additional information and responses to regulatory agency queries, and maintain technical files necessary to obtain and sustain product approvals, while ensuring proper documentation of all regulatory applications and communications with clients and regulatory authorities
- Respond to regulatory queries from clients and agencies, including the Ministry of Health (MOH), Brunei Darussalam, regarding pre-submission strategies, compliance test requirements, and follow-up on submissions under review
- Ensure company operations comply with all applicable government laws and regulations, maintain all licenses required for DKSH's warehouse and distribution services, and write and update Standard Operating Procedures (SOPs), work instructions, and related policies
- Conduct post-market surveillance activities including review of promotional materials, labelling, batch records, specification sheets, and test methods for regulatory compliance, and maintain current knowledge of existing and emerging regulations, standards, and guidance documents
- Participate in internal and external audits, and obtain and distribute updates on domestic and international laws, guidelines, and regulatory standards
- Act as backup Responsible Person for Pharmacovigilance (RPPV), liaising with the National Adverse Drug Reaction Monitoring Centre (NADRMC), Department of Pharmaceutical Services, MOH, Brunei Darussalam for safety information, compliance, and benefit-risk evaluation relating to medicinal products
- Liaise with client Pharmacovigilance (PV) contacts for timely reporting of adverse drug events and expedited submission of reports within stipulated timelines, including medical device expedited reporting, and maintain PV logs, reconciliation report checklists, and PV monitoring data sheets
- Participate in inspections and audits, and support the development and implementation of Corrective and Preventive Action (CAPA) plans
- Provide backup support to ensure branding activities are carried out in accordance with approved procedures and requirements
- Administrative duties and coordination tasks as required, including assisting with physical stock checks for mid-year and financial year-end activities
What You Bring
- Bachelor's Degree in Pharmacy, Life Sciences, or a related field
- Relevant working experience in regulatory affairs or a related fieldStrong knowledge of regulatory requirements and pharmacovigilance practices
- Good command of English, both written and spoken
- Proficiency in office productivity tools including Microsoft Excel, Word, and PowerPoint
Why Join DKSH
At DKSH, we help companies grow in Asia and enable people to perform at their best. You will be part of an organization that values accountability, collaboration, and long-term partnerships. We offer a dynamic environment where your contributions are visible and where you can build a meaningful career in Regulatory Affairs.