JOB DESCRIPTION:
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
MAIN PURPOSE OF ROLE
Handle process of registration of new products, maintenance of all approved products in Vietnam and operate marketed products according to local regulations.
MAIN RESPONSIBILITIES
Registration of New and Existing Products
- Reviews and compiles registration dossier for prompt renewal/initial registration
- 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
- Effects 6-9 months registration plan
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 updated at all times and promptly submits books and records as per schedule
Cross-function Support
- Ensures prompt coordination with other departments/units such as Sales & Marketing 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
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Work Experience
Knowledge of regulations and standards. More than 3 years relevant experience in regulatory affairs.
Education: Bachelor's Degree in pharmacy or Registered Pharmacist in Vietnam
Professional Skill
- Communication
- Customer focus
- Follow-up
- Negotiation
- Problem solving and decision making
Behavioral / Leadership Skill
Apply Abbott Capabilities Framework
Language Skill
- Vietnamese/ Tiếng Việt
- English/Tiếng Anh
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 > Ho Chi Minh City : Me Linh Point Tower
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)