Regulatory Affairs Executive

Job Description:

• Maintain registration database, compile dossiers for production registration, change notifications and renewals according to requirements
• Assist in registration plans for new products, variations, modifications, registration renewals
• Involve in registration complexity analysis, registration plans for new products, variations, modifications and registration renewals
• Assist in collecting and analysing regulatory intelligence, and incorporate regulatory trends into decision-making processes
• Keep track of regulatory requirements changes in the region and support the product labelling with local regulations
• Provide post market regulatory support and guidance as required
• Obtain regulatory /product registration approval for medical products to be marketed in various territories.
• Communicate with Quality Assurance and Quality Control to ensure consistency

Requirements:

· Bachelor degree or above in Pharmacy relevant disciplines

· Minimum 1-year relevant working experience

· Independent, excellent interpersonal and communication skills

· Proficient in MS Office (Outlook, Word, Excel and PowerPoint)

· Overseas travel might be required