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 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.

Regulatory Compliance

• Ensures application of special permits and import certificates at MOH.
• Ensures that all exempt regulated products are MOH verified prior to production use
• Ensures that all product labels/package inserts are updated as approved by MOH’s regulation.
• Keeps registration record always updated and promptly submits books and records as per schedule

Cross-function Support

• Ensures prompt coordination with other departments/units such as Sales, Marketing, Manufacturing Site on regulatory and corporate matters
• Ensures correctness of received documents vs information submitted

Administrative

• Ensures that all technical documents/dossiers and registration samples are kept in secured place
• Maintains proper filing of protocol and other regulatory and clinical related documents
• Keeps updated files of MoH Regulations

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