JOB DESCRIPTION:

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

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Vietnam > Thuan An : Binh Duong Plant 1

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)