RESPONSIBILITIES:
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 and check requests
• Initiates/monitors/updates Regulatory Report in timely manner
Registration of Promotion Materials
• Register and compiles registration dossier for promotional material
• Ensures all promotional materials are lawfully compliance
Regulatory Intelligence
• Be aware of coming new regulation/change that impact to regulatory or business
• Inform head of Department/contacts all change and upcoming new regulations.
• Implement new regulation properly.
REQUIREMENTS:
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