Assistant Manager Regulatory Affairs

• Responsible for daily operation of product registration related activities, pharmacovigilance and controlled drug management for the Healthcare Business Unit of DKSH Singapore.
• Ensure all operational procedures are in compliance with the requirements of the local Regulatory Authorities
• Registered pharmacist for the licences under the Health Products (Therapeutic Products) Regulation and Medicines Act

General responsibilities:

Regulatory Affairs 

• Pre-market activities: product assessment and new product registration
• Post market activities: variation application, product licence renewal and maintenance
• Permit application: named-patient permit, advertising permit & sale promotion permit and any permit to allow importation or exportation. 

Pharmacovigilance (PV) 

• Receive and review individual case safety report (ICSRs) for accuracy and completeness.
• Follow up with reporter for clarification and completion when necessary
• Report ICSR and safety information to clients and health authority within stipulated timelines
• Train relevant persons regarding safety information, pharmacovigilance, medical device vigilance and other healthcare products
• Manage pharmacovigilance, medical device vigilance and other healthcare products database
• Manage relevant aspects of safety agreement with clients
• Manage and ensure compliant safety reporting in according with standard procedures, safety agreement and local regulations.  
• Coordinate with clients and relevant functions for FSCA reporting to health authority within stipulated timelines
• Responsible for clients and health authority audits
• Responsible for PV reconciliation with clients

Registered Pharmacist

• Managing controlled drug distribution: inbound, outbound, daily stocks reconciliation, maintenance of manual records, reporting to HSA, destruction and security audit
• Ensure compliance to the licensing requirements in the importation, wholesale and distribution of health products:
  • focusing on the management of authorised activities and the accuracy and quality of records
  • ensuring that suppliers and customers are legally approved or authorised to enable lawful supply of health products
• Ensure SOPs and documentations are properly maintained.
• Manage and work closely with different internal stakeholders and clients to establish a collaborative effort to achieve fulfillment of deliverables.

Job Requirements:

• Possess a Degree in Pharmacy
• Registered Pharmacist with Singapore Pharmacy Council
• Comes with more than 2 years of experience in pharmaceutical industry setting
• Able to work independently and in teams
• Excellent time management
• Strong proficiency in MS office application

Office location: 47 Jalan Buroh