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.

Communicatewith Quality Assurance and Quality Control to ensure consistency

Requirements:
· Bachelor degree or above inPharmacy relevant disciplines

· Minimum 1-year relevantworking experience

· Independent, excellentinterpersonal and communication skills

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

· Overseas travel might berequired