https://i0.wp.com/www.kensington.co.th/wp-content/uploads/2016/11/kens-hi_Small_centred.jpg?fit=257%2C250 250 257 Vic Allen http://www.kensington.co.th/wp-content/uploads/2016/05/kensington_associates-Recruitment-340x69.jpg Vic Allen2016-11-09 12:45:142016-12-12 00:41:52Regulatory Affairs Specialist for Veterinary Products (Animal Health)
- 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.
- 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