Regulatory Affairs Officer - Binh Duong
Abbott
**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.
**What You’ll Do**
**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
**Required Qualifications**
**MINIMUM BACKGROUND/ EXPERIENCE REQUIRED**
+ **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
**MINIMUM EDUCATION REQUIRED**
+ Bachelor’s degree in Pharmacy
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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