Regulatory Affairs Executive

BriefSummary

JoinadynamicteamasaRegulatoryAffairsSpecialist,whereyouwillplayapivotalroleinmanagingproductcomplianceandnavigatingregulatorylandscapes.ThispositionoffersanopportunitytodriveimpactfulchangesacrosstheproductlifecycleinSingaporeandMalaysia.

Responsibilities

• Manage the lifecycle of the product portfolio, ensuring regulatory compliance and continuity of supply in Singapore and Malaysia.
• Prepare, compile, and submit high-quality registration dossiers to secure timely regulatory approvals and maintain product registrations and licenses.
• Handle regulatory activities for new product registrations, renewals, and variations, while assessing the impact of product changes.
• Liaise with regulatory authorities regarding submissions, queries, and commitments to ensure alignment with local and regional standards.
• Collaborate with cross-functional teams to support product launches and compliance efforts, maintaining accurate records and regulatory documentation.

Requirements

• Bachelor's Degree in Pharmacy, Pharmaceutical Science, Life Sciences, or a related discipline.
• Minimum of 2 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Comprehensive understanding of regulatory requirements and their impact on product registrations and compliance.
• Proven ability to manage multiple regulatory activities effectively and deliver results within set timelines.
• Strong problem-solving and organizational skills with attention to detail.
• Excellent communication skills, with the ability to articulate regulatory requirements and influence stakeholders.