Regulatory Affairs Executive

Labgistics Limited; Singapore; On-site; SGD 56,000 - 100,000; Full time

Job summary

LABGISTICS Asia Pte Ltd in Singapore seeks a Pharmacist to lead regulatory affairs and QA activities for local and regional distribution. You will direct regulatory compliance, coordinate license applications and license renewals, and ensure documentation integrity across the product lifecycle.

The ideal candidate holds a Pharmacy degree registered with the Singapore Pharmacy Board, has at least 2 years’ pharmacy experience, and can communicate fluently in English.

Qualifications

• Pharmacy degree and registration with relevant board.
• Knowledge of regulatory requirements for licenses and variations a must.
• Strong documentation and record-keeping skills required.

Responsibilities

• Train and coordinate regulatory guidance for license applications and renewals.
• Liaise with regulatory bodies on regulatory affairs matters.
• Align inter-department processes and SOPs with local regulations and standards.
• Manage local permits and licenses applications, renewals and maintenance.
• Review product dossiers for submissions including variations for therapeutic products and medical devices.
• Maintain and file current licenses and registration documents.
• Collaborate with QA and Operations on logs and records for traceability of products.
• Ensure SOP compliance with local regulations and recognized standards.
• Handle regulatory matters related to sales and distribution of medical devices and controlled products.
• Submit reports and license-related transactions as required by licenses and permits.
• Participate in meetings to review registrations, renewals and amendments.

Skills

Regulatory affairs

Quality assurance

GMP knowledge

Documentation

Communication skills

Education

Pharmacy degree

Job description

This role is part of LABGISTICS Asia Pte Ltd's (LABG) QRA department under the Commercial Support Services Division. The jobholder will provide strategic direction and alignment for the Quality Assurance (QA) and Quality Control (QC) functions at our distribution sites located locally & regionally. You will direct and support our quality assurance efforts and promote a culture of quality assurance, compliance, and continuous improvement. Successful candidate will report to LABG’s Head of QRA.

Responsibilities:

• Train the local team on the preparation of documents for license applications and maintenance including new product launches and existing products

• Be the main liaison with regulatory and government bodies regarding Regulatory Affairs

• Be the main liaison for inter-department alignment of work processes/procedures as required

• Responsible for local permit & licenses application, renewals and maintenance

• Review and prepare product dossiers for submission, including variations (therapeutic products, medical device etc.)

• Maintenance and filing of current product licenses and registration documents

• Liaise with QA and Operations on the periodic and routine review of logs and records for movement and traceability of products

• Ensure the compliance of our Standard Operating Procedures (SPs/SOPs/Wis) in accordance with local regulations & certified-bodies standards

• Attend to all regulatory matters relating to the sales and distribution of Medical Devices, Radioactive Therapeutic Products & Controlled Drug, this list remains non-exhausive

• Submission of reports and transactions of our companies’ assigned licenses and permits required by respectively

• Participate in meetings with the local Regulatory Affairs team to review status of registrations, renewals and amendments including projects and other activities of the department

• Carry out any other duties assigned from time to time by the Director or Business Manager/General Manager

Requirements:

• Pharmacy Degree registered with Singapore Pharmacy Board

• Familiar with the registration requirements for Form A Poison License and Controlled Drug License / Therapeutic Products / Medical Devices

• Able to communicate fluently in written and verbal English

• Working experience as Pharmacist for at least 2 years