Regulatory Affairs Executive - JL

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

Job summary

PASONA SINGAPORE PTE. LTD. is seeking a Regulatory Affairs Executive to oversee regulatory submissions and product life cycle management for Singapore and Malaysia.

The role requires collaboration across Supply Chain, Commercial, Medical, and Quality teams to ensure timely approvals and continuity of supply. The ideal candidate holds a Bachelor’s in pharmacy or related field with at least 2 years of regulatory experience in Singapore.

Qualifications

• Bachelor's degree in pharmacy, Pharmaceutical Science or related field.
• At least 2 years of Regulatory Affairs experience in Singapore.
• Experience preparing and managing regulatory submissions in Singapore.
• Understanding regulatory requirements and impact on registrations and supply.
• Experience managing product life cycle activities including variations and health authority queries.
• Ability to manage multiple regulatory activities to deadlines.

Responsibilities

• Manage life cycle of existing product portfolio in Singapore and Malaysia.
• Prepare, compile, review and submit registration dossiers for regulatory approvals.
• Manage regulatory activities for new registrations, renewals, variations and post-approval commitments.
• Review product change requests and advise on regulatory actions and submission pathways.
• Oversee labelling changes and packaging compliance.
• Liaise with health authorities on submissions and queries.
• Provide regulatory input for Singapore and Malaysia strategies.
• Collaborate with Supply Chain, Commercial, QA and other functions.
• Maintain regulatory databases and submission trackers.

Skills

Regulatory affairs

Dossier submissions

Regulatory compliance

Cross-functional coordination

Education

Bachelor's degree in pharmacy

Pharmaceutical Science

Job description

Position: Regulatory Affairs Executive (1 Year Renewable Contract) (Job ID: 20394)

• Pharmaceutical company
• Clarke Quay MRT
• Basic Salary (Up to $4,500) + Completion Bonus

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.

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:

2) Quality Assurance/Quality Management

• 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, documentation quality and the execution of regulatory activities.
• Support the onboarding and training of new team members and contribute to knowledge sharing across the Singapore and Malaysia teams.
• Perform other regulatory and quality related duties assigned based on business needs and the employee’s qualifications and authorised responsibilities.

Job Requirements

MUST HAVE

• Bachelor's degree in pharmacy, Pharmaceutical Science, Life Sciences or another relevant discipline.
• At least 2 years of Regulatory Affairs experience within the Singapore pharmaceutical industry.
• Demonstrated experience in preparing and managing regulatory submissions and post approval activities in Singapore.
• Comprehensive understanding of regulatory requirements and the potential impact of regulatory activities and product changes on product registrations, supply, labelling and related business processes.
• Experience in managing product life cycle activities, including variations, renewals, change assessments, labelling updates and health authority queries.
• Ability to independently manage multiple regulatory activities and deliverables within agreed timelines.

Preferred Qualifications and Experience

• Bachelor's degree in pharmacy
• Registered pharmacist with the Singapore Pharmacy Council and eligible to be appointed as the Responsible Person for the company's Therapeutic Products Importer's Licence and Wholesaler's Licence.
• Regulatory Affairs experience within the Malaysia pharmaceutical industry, including familiarity with National Pharmaceutical Regulatory Agency requirements.
• Experience supporting regulatory activities across both Singapore and Malaysia.
• Experience with different product types, such as chemical drugs, biologics and drug device combination products.
• Knowledge of Good Distribution Practice requirements and experience supporting quality operations, health authority inspections or self-inspections.