Regulatory Affairs Executive

Abbott View all jobs

  • Hanoi
  • Permanent
  • Full-time
  • 25 days ago
JOB DESCRIPTION:About ABBOTTAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. As Senior Talent Acquisition Manager, you will play a critical role in setting the strategy and leading a team of internal recruiters and external partnerships to effectively attract, hire, and maintain a continuous pipeline of well-qualified talent.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.The primary scope of the Regulatory Affairs Executive role is including:
  • Execution: Ensure the implementation of RA strategies according to the guidance of the RA director/manager in preparing dossier and registering with the Ministry of Health to obtain and maintain product licenses; product advertising certification; internal review promotional material to ensure compliance.
  • External engagement with Health authority: follows up with Health authority to ensure product registration smoothly, got the product licenses on time with key claims protected, gather regulatory intelligence.
  • Cross-functional support: provide information related to regulation and product to support cross functions team, perform RA team administrative tasks.
Preparing dossier for Products registration, product advertising registrationInternal Review Promotion MaterialsFollows up with Health AuthorityNegotiation with Health AuthorityGather regulatory intelligence.Provide product technical information, regulation to support other functionsAct as regulatory consultant to other functionsPerform administrative taskMINIMUM BACKGROUND/ EXPERIENCE REQUIRED
  • At least 1 years (Years of experience in overall Nutrition/ Pharmacy/ Medicine industry or specific in regulatory affairs)
  • Good technical knowledge on nutrition or pharmacy or medicine.
  • Communication skill: Clearly conveying information and ideas to Health authority to engages and helps them understand and accept company’s submission.
  • Follow-up: Closely monitoring the product registration process and timely report to RA director/manager, respond to Health authority's request under instruction from RA director/manager
  • Negotiation skill: Effectively exploring alternatives and positions to reach outcomes that gain the acceptance for product submission
  • Adaptability, Initiative, Innovation, Integrity, Teamwork
  • English B1 (Reading, Writing, Listening, Speaking)
The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION:LOCATION: Vietnam
Hanoi : Handi Resco TowerADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott