Regulatory Affairs Specialist for Veterinary Products (Animal Health)

  • Full Time
  • Bangkok
  • Applications have closed

Job Responsibilities:

  • Prepares registration dossiers and labels according to regulatory requirements and relevant government regulations for animal vaccines for all countries in Asia;
  • Interfaces with Regional and Country Regulatory Affairs Departments for registrations of new veterinary products, especially vaccines, in Asia but also other continents.
  • Maintains product licenses and documentation according to regulatory requirements in each country.
  • Involvement in the planning, coordination and implementation of defined projects;
  • Cooperation with internal and external partners, e.g. global, regional and country R&D, RA, QM, QC as well as with 3rd-party research organizations and animal health companies to provide regulatory support during product development, registration and after product launch.
  • Provides support for planning of registration trials and consider requirements for product registrations.
  • Organizes certificates (free sales certificates, etc.) and product samples. • Liaises and works closely with the related authorities;
  • Monitors changes of regulations and providing suggestions to management if adaptation is needed.
  • Support creation of RA budgets (FSC, trials, translations, consultants, travels, other minor expenses)
  • Interface with Marketing Departments to update all information about labels, regulations and reports in dossiers.

Requirements:

  • Bachelor degree in veterinary medicine or equivalent
  • Good command of written and spoken English
  • Possess excellent communication and negotiation skills, especially with regard to dealing with regulatory authorities.
  • Possess analytical skills, meticulous and precise
  • Flexible and willing to take initiative
  • Able to make decisions and take responsibility within their scope of work
  • Willing to be based in Bangkok, Thailand