Associate Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi)

Abbott

  • Hanoi
  • Permanent
  • Full-time
  • 8 days ago
JOB DESCRIPTION:ABOUT ABBOTTAbbott 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 ABBOTTAt 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.
MAIN PURPOSE OF ROLE
  • Product registration including new, renewal, variations, special import license, promotional materials…
  • Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management…
  • Other tasks assigned by the line manager.
MAIN RESPONSIBILITIES
  • Contact with DAV, MOH and relevant Authorities:
Liaise with government to ensure regulatory compliances.
Establish and maintain positive relationship with government agencies and other regulatory authorities. * Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement…) following the regulation. Supervise the registration of marketed product.
  • Liaison with various distributors/consultants/DAV (Drug Administration of Vietnam) to facilitate the smooth registration activity
  • Understand and share current updates in regulations/new guidelines/circulars published by DAV
  • Evaluate and review registration dossiers for administration
  • Keep track of registration status, submissions and registration timeline
  • Closely follow up the status of application from the time of submission until getting approval
  • Support Marketing team in applying advertisement licenses & detail aid material printing permits
  • Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Abbott products.
MINIMUM BACKGROUND/ EXPERIENCE REQUIREDWork Experience:
3 years experience in Regulatory, prefer pharmaceutical MNCCORE Skills Required:
Professional Skill
  • Time management
  • Persuasiveness
  • Good in working arrangement, teamwork
  • Honest, careful, patient, highly responsible
Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
Language Skill: Vietnamese/ Tiếng Việt & English/Tiếng Anh
Computer Skill: MS officeMINIMUM EDUCATION REQUIRED
  • Bachelor’s degree in Pharmacist or Medical Doctor
The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: EPD Established PharmaLOCATION: Vietnam
Hanoi : Handi Resco TowerADDITIONAL 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