Assistant Manager Regulatory Affairs

About the role

The Assistant Manager Regulatory Affairs will oversee daily product registration, pharmacovigilance and controlled drug management for DKSH's Healthcare Business Unit in Singapore. This role ensures all activities comply with local regulatory authority requirements and supports both pre‑market and post‑market processes.

Key responsibilities

• Conduct product assessments and manage new product registrations.
• Handle variation applications, licence renewals and maintenance.
• Prepare and submit named‑patient, advertising and sales promotion permits, as well as import/export permits.
• Receive, review and report individual case safety reports (ICSRs) in line with pharmacovigilance timelines.
• Train internal teams on safety information, pharmacovigilance and medical device vigilance.
• Maintain databases for pharmacovigilance, medical device vigilance and other healthcare products.
• Coordinate safety reporting with clients and health authorities, ensuring compliance with agreements and local regulations.
• Manage controlled drug inventory, reconciliation, reporting to HSA and security audits.
• Ensure SOPs and documentation are up‑to‑date and that suppliers and customers are authorised.
• Collaborate with internal stakeholders and clients to meet deliverables.

Required profile

• Degree in Pharmacy.
• Registered Pharmacist with the Singapore Pharmacy Council.
• Minimum 2 years experience in the pharmaceutical industry.
• Ability to work independently and as part of a team.
• Strong time‑management skills.

Required skills

• Microsoft Office proficiency.