Senior Regulatory Affairs Executive - Pharmaceuticals Division

JOB DESCRIPTION:

ABOUT ABBOTT

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

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.

In Vietnam, Abbott’s Established Pharmaceuticals Division has committed to enhance the care of patients. Our products cover several therapeutic areas, including gastroenterology, women health, cardiology, primary care, specialty and food supplement. Our key prescription products include Lipanthyl, Klacid, Duphaston, Drosperin and BetaSerc. Our key over-the-counter products are Duphalac, CG210, Estraceptin, Brufen, Fatig, Surbex. We also have the Influvac vaccine.

MAIN PURPOSE OF ROLE

Experienced professional individual contributor that works under limited supervision.

Apply subject matter knowledge in the area of Regulatory Affairs.

Require capacity to apply skills/knowledge within the context of specific needs or requirements.

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/ variation registration

Ensures availability of updated registration documents/samples

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 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

BACKGROUND/ EXPERIENCE REQUIRED

Bachelor of Pharmacy

Strong knowledge of Vietnamese pharmaceutical regulations.

Minimum 3 years of experience in Regulatory Affairs, preferably with a local pharmaceutical company.

Experience in R&D or QA or QC will be an added advantage.

Language skills: Vietnamese, English

Computer skills: MS Office

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)