Assistant Manager Regulatory Affairs

About the Role

The Assistant Manager, Regulatory Affairs is responsible for ensuring the compliant and efficient management of controlled drugs, pharmacovigilance, and regulatory submissions within DKSH Singapore's Healthcare Business Unit. This role is critical to upholding DKSH's regulatory integrity and supporting the lawful distribution of healthcare products across Singapore.

What You Will Deliver

• Supervise controlled drug distribution across inbound and outbound supply chains, ensuring full compliance with the Misuse of Drugs Regulation


• Maintain 100% stock accountability through daily and monthly stock counts, with records consistently meeting regulatory requirements


• Manage import and export licence applications for controlled drugs and psychotropic products, including annual reporting to the Health Sciences Authority (HSA)


• Coordinate controlled drug destruction processes and deliver compliance training to relevant staff


• Act as the Local Primary Pharmacovigilance Responsible Person, overseeing the receipt and review of Individual Case Safety Reports (ICSRs) for accuracy and completeness


• Ensure timely reporting of ICSRs and safety information to clients and health authorities within stipulated timelines


• Coordinate with clients and relevant functions to facilitate Field Safety Corrective Action (FSCA) reporting to health authorities within stipulated timelines


• Manage pharmacovigilance reconciliation with clients and ensure all activities align with pharmacovigilance agreements, standard procedures, and local regulations


• Oversee licence applications for special access routes and the import and export of psychotropic products


• Ensure compliance with licensing requirements for the importation, wholesale, and distribution of health products, including verification that suppliers and customers are legally authorised for lawful supply


• Manage HSA and client audits across controlled drug and pharmacovigilance functions, ensuring readiness at all times


• Collaborate with internal stakeholders and clients to drive aligned delivery of regulatory commitments


• Administrative duties and coordination tasks as required

What You Bring

• Degree in Pharmacy or relevant science degree


• More than 2 years of experience in the pharmaceutical and/or medical devices industry


• Proficiency in Microsoft (MS) Office applications


• Strong team collaboration and time management capabilities

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 Operations.