Thailand

งานในประเทศไทย

Responsible for all activities pertaining to product registration as per regulatory requirements such as product registration, amendment and promotional materials submission as assigned, ensuring strict compliance to the FDA’s regulations. Prepares and follow up regulatory submissions to ensure the timely registration of new products and maintain existing registrations. Liaises with company affiliates both locally and internationally on regulatory issues.

  • Coach and assists team on preparation of all regulatory submissions to ensure successful submission of company products.
  • Prepares submissions of product registration and product variation as Thai FDA requirement to ensure successful regulatory submission of company products.
  • Analyzes the scientific content of assigned products to ensure compliance with government regulations prior to submission.
  • Reviews artwork and packaging changes and recommend action.
  • Keeps up-to-date and foresee the impact of government regulation and legislation
  • Assists Marketing Department in obtaining approval from FDA on promotional materials.
  • Review regulatory related-reports for periodical submission to government authorities.
  • Liaises with industry associates and officers to facilitate the company’s business.
  • Coordinate with supply chain on implementation plan of each assigned product
  • Ensure the regulatory related-database up-to-date.
  • Be a role model and ensure teams follow the Compliance and HSE Policy

#LI-SEA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.



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