Regulatory Affairs Executive - Abbott Pharmaceutical (Based in Binh Duong)

Registration of New and Existing Products• Reviews and compiles registration dossier for prompt renewal/initial/variation registration• Maintains Marketing Authorizations in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems (e.g. change control, product labelling, etc.) are in place.• Ensures availability of updated registration documents/samples• Weekly follow up with the authorities as needed.• Fast requisition of dossier...

Work Experience:• Knowledge of regulations and standards.• More than 3 years relevant experience in regulatory affairs.Competency:• Communication & negotiation skills• Problem-solving,• Analytical thinking• Team working…Language Skill:• Fluent in English – written and spoken communication skills