Regulatory Affairs Manager

VISIT US            

   Full Time and Permanent
   02 634 8884

Regulatory Affairs Manager

Job Description:

  • Responsible for Pharmaceutical product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations.
  • Prepare registration dossier according to FDA requirement and prepare the documents for post approval changes liaising with FDA requirements.
  • Timely communicate internal teams about updates from Thai FDA on registration status and regulatory relevant activities.
  • All required elements for product registration are scheduled correctly and in place to meet the target filing and registration dates.
  • Submission of Pharmaceutical products for registration and follow up with FDA to obtain timely or earliest approvals.
  • Able to manage in technical skills including regulatory and product quality perspectives.
  • Coordinate with internal and global regulatory team to ensure that the registration dossier, packaging artworks meet the requirements of Thai FDA and properly manage and resolve the issues.
  • Support and work closely with cross functional teams such as sales & marketing and quality team of relevant issues.
  • Responsible for all activities of RA and relevant related RA activities.


  • Bachelor’s degree in Pharmaceutical Science
  • Minimum 5 years working experience in regulatory affairs area (experience in pharmaceutical/biological product in an advantage)
  • Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
  • Understanding of the rules and regulations for Pharmaceutical/Biological products.
  • Good command in English (speaking, reading and writing)
  • Good at computer skills (MS Office, MS Excel, Adobe etc.)
  • Male or Female, aged between 30-40


We are committed to protect and use your personal data in accordance with Thailand Privacy Principles under the Personal Data Protection Act B.E.2562 (2019) (“PDPA”) and our data privacy policies. In addition, we maintain the appropriate technical and organizational measures to protect your personal data against unauthorized or unlawful processing and/or against accidental loss, alteration, disclosure or access, or accidental or unlawful destruction of or damage thereto.
By submitting your email address and any other personal information to this website, you consent to such information being collected, held, used and disclosed in accordance with our PRIVACY POLICY.
Scroll to top