Regulatory Affairs Officer - Abbott Pharmaceuticals (Third-party contract)
Abbott Laboratories · Hanoi
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.
ROLES & RESPONSIBILITIES
MAIN PURPOSE OF ROLE
Support regulatory lifecycle management for assigned legacy products through effective regulatory operations, documentation management, submission support, and maintenance of regulatory records to ensure ongoing compliance with local regulatory requirements.
MAIN RESPONSIBILITIES
- Support regulatory maintenance and product lifecycle activities for assigned legacy products.
- Prepare, organize and upload registration dossiers and supporting documentation to the Drug Administration of Vietnam (DAV) portal for regulatory submissions.
- Coordinate submission readiness activities for new product registrations, marketing authorization (MA) extensions, variations, GMP listings, Innovator listings and Bioequivalence (BE) listings.
- Maintain complete and accurate regulatory documentation, including electronic and hard-copy archiving of submissions, approvals and related records.
- Track and maintain regulatory databases, submission trackers and registration records to ensure data integrity, regulatory compliance and timely completion of activities.
- Collaborate with internal stakeholders to support regulatory operations and ensure adherence to company procedures and local regulatory requirements.
- Perform other duties and responsibilities as assigned by the manager to support regulatory operations, business objectives and organizational priorities.
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
- Bachelor's Degree in pharmacy or Registered Pharmacist in Vietnam
- Knowledge of regulations and standards.
- From 1 year relevant experience in regulatory affairs.
- Good English communication
- Proficient working with systems and managing large volumes of data.
- Compliance mindset
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