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 registrationMaintains 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/samplesWeekly follow up with the authorities as needed.Fast requisition of dossier and check requestsInitiates/monitors/updates Regulatory Report in timely manner

Registration of Promotion Materials

Register and compiles registration dossier for promotional materialEnsures all promotional materials are lawfully compliance

Regulatory Intelligence

Be aware of coming new regulation/change that impact to regulatory or businessInform 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 useEnsures 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 mattersEnsures correctness of received documents vs information submitted

Administrative

Ensures that all technical documents/dossiers and registration samples are kept in secured placeMaintains proper filing of protocol and other regulatory and clinical related documentsKeeps 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.

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