Senior Regulatory Affairs Executive – Abbott Pharmaceuticals – Based in Binh Duong

Job Description


JOB DESCRIPTION:

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 Inteligence
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-funtion 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
REQUIREMENTS

Education
. University Degree (Medical Doctor, Pharmacist)
Experience
. Knowledge of regulations and standards.
. More than 1 years relevant experience in regulatory affairs.
Knowledge/ Skills
. English
. Computer
Others
. Continuous Improvement behaviorJOB FAMILY:
Regulatory OperationsDIVISION:
LOCATION:
Vietnam Thuan An : Binh Duong Plant 1ADDITIONAL LOCATIONS:
WORK SHIFT:
StandardTRAVEL:
Not specifiedMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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