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.
