Ho Chi Minh City, VNM
6 days ago
Regulatory Affairs Officer - Binh Duong
**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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