Regulatory Associate 1

• Ensure compliance of products, raw materials, packaging, labels, manufacturing processes, and facilities with FDA, Halal, DTI, PDEA, and other regulatory requirements.
• Prepare and submit regulatory documents for product registrations, facility licenses and permits, renewals, product changes, and regulatory approvals.
• Coordinate with regulatory agencies on inspections, audits, meetings, submissions, approvals, and other regulatory matters.
• Review, maintain, and update regulatory dossiers, labeling, product documentation, records, and change control requirements.
• Monitor regulatory updates, develop compliance strategies, and support timely product approvals and regulatory compliance.
• Lead audit readiness, respond to regulatory findings (CAPA), and support post-market activities, including adverse event reporting and product defect management.

Qualifications:

• Registered Pharmacist with 1-3 years of relevant experience
• Proven knowledge to understand various regulations and policies in local and export (cosmetics, food and drug), project management and relevant skills
• Able to understand various regulations locally and abroad including Halal
• Strong project management skills and attention to details
• Strategic thinking to effectively navigate complex situations
• Proficient in MS Office (Word, Excel, PowerPoint).