Regulatory Affairs Manager

VISIT US            

   Bangkok
   Full Time and Permanent
   Pharmaceutical
   Negotiable
   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.

Qualifications:

  • 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

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