Assistant Manager Regulatory Affairs

Singapore - Singapore

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

The role oversees the daily operations of product registration pharmacovigilance and controlled drug management for the Healthcare Business Unit of DKSH Singapore. It includes ensuring that all operational procedures comply with the requirements set by local regulatory addition the position serves as the registered pharmacist for licences under the Health Products (Therapeutic Products) Regulations and the Medicines Act.

This position reports to Senior Manager Medical Affairs.

Key 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.

Key Requirements:

Registered Pharmacist with the Singapore Pharmacy Council
Strong team player with effective collaboration skills
Proven time management and organizational abilities
Proficient in Microsoft Office applications
Possess a bachelors degree in Pharmacy
Over one year of experience in a pharmaceutical industry environment

Note: The role requires full 5 days onsite based at our Jalan Buroh site.

Required Experience:

Manager