Regulatory Affairs Executive

Regulatory Affairs Executive (Contract Basis) (Ref: 37818)
Location: Central

【 Responsibilities 】

1) Regulatory Affairs

• Manage product registrations and product life cycle activities in Singapore and Malaysia.
• Handle new product registrations, renewals, variations, change notifications and other post-approval activities.
• Review product labelling, packaging materials and promotional materials to ensure compliance with applicable regulatory requirements.
• Prepare and submit regulatory dossiers and respond to queries from HSA, NPRA and other relevant regulatory authorities.
• Monitor regulatory changes and provide regulatory updates and impact assessments to relevant stakeholders.
• Work closely with Supply Chain, Commercial, Medical, Pharmacovigilance, Quality and other functions to support product launches, product changes and continuity of supply.
• Maintain regulatory databases, submission records and related documentation.
• Identify opportunities to improve regulatory processes and operational efficiency.

2) Quality Assurance / Quality Management

Applicable where the employee is formally appointed as the Responsible Person.

• Act as the Responsible Person for the Therapeutic Products Importer’s Licence and Wholesaler’s Licence.
• Oversee GDP-related quality activities covering product importation, storage and distribution.
• Oversee product release, returns, recalls, holds and other product disposition activities, as applicable.
• Support health authority inspections and GDP self-inspections.
• Support the management of deviations, product complaints, CAPA and other quality-related matters.
• Support the oversight of distributors, logistics service providers and relevant third parties.

3) Others

• Review promotional and non-promotional materials for compliance with applicable regulatory requirements.
• Collaborate with local, regional and global stakeholders to ensure the timely completion of regulatory and quality activities.
• Support regulatory activities in Malaysia and work closely with the Malaysia regulatory team.
• Support regulatory and quality audits and inspections.
• Guide and support junior team members and new joiners.
• Perform other regulatory and quality-related duties as assigned based on business needs.

【 What you will receive 】

• Variable bonus: One month’s variable bonus upon contract renewal
• Annual Leave: 14 days (up to a maximum of 20 days.)
• Medical Leave
• Medical Benefits
• Flexible Benefits: up to S$1,500 per year

【Requirements & Preferences】

• Bachelor’s degree in Pharmacy, Pharmaceutical Science, Life Sciences or another relevant discipline.
• At least 2 years of relevant Regulatory Affairs experience in the Singapore pharmaceutical industry, with specific experience in therapeutic products.
• Proficiency in English to communicate effectively with relevant internal and external stakeholders.
• Demonstrated experience in preparing and managing regulatory submissions and post-approval activities in Singapore.
• Strong understanding of regulatory requirements and their potential impact on product registrations, supply, labelling and related business processes.
• Experience in managing product life cycle activities, including variations, renewals, change assessments, labelling updates and responses to health authority queries.
• Ability to independently manage multiple regulatory activities and deliverables within agreed timelines.

(Advantageous)

• Registered pharmacist with the Singapore Pharmacy Council and eligible for appointment 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.
  
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  We regret that only shortlisted candidates will be notified.
  
  Registration No.: R1874034 (Niltasha Binte Ibrahim)
  Recruitment Licence: 12C5051