Regulatory Affairs Executive (Contract) - JY

PASONA SINGAPORE PTE. LTD.; Singapore; On-site; SGD 46,000 - 55,000; Full time

Job summary

PASONA SINGAPORE PTE. LTD. in Clarke Quay, Singapore, seeks a Regulatory Affairs professional to manage Singapore and Malaysia regulatory lifecycle, ensuring timely approvals and continuity of product supply.

The role also covers Quality Assurance duties, including GDP compliance and liaising with health authorities, with opportunities to mentor junior staff and contribute to continuous improvement.

Qualifications

• Regulatory lifecycle management for Singapore and Malaysia.
• Prepare and submit registration dossiers for approvals.
• Manage variations, renewals, and post-approval commitments.
• Review labelling and artwork for compliance.
• Track submissions and maintain regulatory records.
• Liaise with HSA, NPRA and other authorities.

Responsibilities

• Regulatory lifecycle management for Singapore and Malaysia.
• Prepare and submit registration dossiers for approvals.
• Manage variations, renewals and post-approval commitments.
• Review product labelling and packaging for compliance.
• Track submissions and maintain regulatory documentation.
• Coordinate with cross-functional teams for launches and supply.
• Oversee GDP quality activities and product disposition (if appointed).
• Support inspections and audits by health authorities.
• Review promotional materials for regulatory alignment.
• Collaborate with regional and global teams to ensure timely regulatory actions.

Job description

Location: Clarke Quay

Working hours: 9am - 6pm

Salary: up to $4,500 (Depending on experiences)

Job Description

1) Regulatory Affairs

• Manage the life cycle of the existing product portfolio in Singapore and Malaysia, while supporting regulatory compliance and continuity of product supply.
• Prepare, compile, review and submit high-quality registration dossiers to obtain timely regulatory approvals and maintain existing product registrations and licences in Singapore and Malaysia.
• Manage regulatory activities relating to new product registrations, renewals, variations, change notifications and other post approval commitments.
• Review product change requests, assess their regulatory impact and recommend appropriate regulatory actions, submission pathways and implementation timelines.
• Manage labelling changes, safety updates, artwork development and approval of packaging material components in accordance with applicable regulatory requirements and company procedures.
• Review proposed product labelling and packaging materials to ensure compliance with approved product information, product branding, global or regional standards and applicable local requirements.
• Track submission progress, maintain accurate regulatory records and manage responses to health authority queries within the required timelines.
• Liaise with the Health Sciences Authority, National Pharmaceutical Regulatory Agency and other relevant authorities, as applicable, on regulatory submissions, queries and commitments.
• Monitor changes in regulatory requirements and provide relevant regulatory intelligence and impact assessments to local, regional and global stakeholders.
• Provide regulatory input and support the development and implementation of regulatory strategies for Singapore and Malaysia.
• Work closely with Supply Chain, Commercial, Medical, Pharmacovigilance, Quality and other relevant functions to support product launches, product changes and continuity of supply.
• Maintain accurate and current regulatory databases, submission trackers, product registration records and regulatory documentation.
• Support the development, review, implementation and maintenance of applicable regulatory procedures, work instructions and training materials.
• Identify opportunities to improve regulatory processes, documentation quality and submission efficiency while maintaining compliance with applicable requirements.

2) Quality Assurance/Quality Management

The following responsibilities apply if the employee is eligible and formally appointed as the Responsible Person for the company's Therapeutic Products Importer's Licence and Wholesaler's Licence:

• Serve as the company's Responsible Person for the Therapeutic Products Importer's Licence and Wholesaler's Licence and fulfil the responsibilities associated with the appointment.
• Oversee local Good Distribution Practice operational quality activities, including product release, product hold, product return, product recall and other product disposition activities, as applicable.
• Ensure that products are imported, stored and distributed in accordance with applicable licence conditions, Good Distribution Practice requirements and company procedures.
• Support or lead inspections conducted by the health authority and coordinate the preparation, follow up and closure of inspection observations.
• Plan and perform Good Distribution Practice self-inspections and ensure that identified actions are documented, monitored and completed within the agreed timelines.
• Support the management of deviations, product complaints, corrective and preventive actions and other quality matters, where applicable.
• Support oversight of distributors, logistics service providers and other relevant third parties to ensure compliance with applicable quality agreements and Good Distribution Practice requirements.
• Support the preparation, review and maintenance of quality agreements relating to importation, storage and distribution activities.
• Escalate significant quality issues promptly and support appropriate investigation, risk assessment and corrective actions.

3) Others

• Review promotional and non-promotional materials to ensure alignment with approved product information, applicable regulatory requirements and company procedures.
• Collaborate effectively with cross functional stakeholders, regional and global teams, external partners and service providers to ensure consistent compliance and timely delivery of regulatory and quality activities.
• Provide regulatory support for Malaysia activities and work closely with the Malaysia regulatory team to ensure timely submissions, responses and implementation of approved changes.
• Support regulatory and quality audits and inspections, including preparation of requested documentation and follow up of resulting actions.
• Guide and coach junior team members on regulatory requirements, company procedures, docum