Providing support to regulatory related timely submissions and registration maintenance, other activities assigned as appropriate
Responsible for dossier compilation to ensure ready to submit dossier is available as per Thai FDA requirements
Maintains full awareness of all regulatory activities on assigned projects and communicates that project deadlines and performance standards for these projects are established and met.
Ensure labelling compliance with latest Thai requirements.
Support promotional material processes in Thai language.
Ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate systems in line with applicable internal company standards
Liaise with Regional RA and local Regulatory Authority to ensure full local regulatory and company compliance
At least 1-2 years relevant work experience in RA field, including Health Authority Interaction
Relevant scientific background, Bachelor’s Degree in Pharmacy preferred
Good English verbal and written communication skills
With ability to work effectively with RA partner outside Thailand
Demonstrated good organization and project management skills and ability to multitask, detail oriented with high standard within tight deadline
Merck Ltd. celebrated 28th anniversary in Thailand after it had been established in 1991 as a joint-venture between Merck KGaA, Germany and B. Grimm (Thailand). As one of the leading company conducting business in Healthcare, Life Science, and Performance Materials, we contribute products and services not only to meet the needs and satisfaction of customers in pharmaceutical, scientific, and chemical industries, but also make the great things happened for lives.
Apart from head office located in business area at the central of Bangkok, we have a Chemicals Distribution Center (CDC) at Bangpoo Industrial Estate, where is approximately 38 km. from Bangkok. This warehouse facilitates storing a sufficient local stock of chemical products in order to meet high availability, delivery and service standards. http://www.merck.co.th
WE ARE MERCK, we've been around for 350 years, yet our majority owners are still the descendants of Friedrich Jacob Merck, the man who founded our company in Darmstadt, Germany in 1668. Since then, we have become a truly global company, with 52,000 employees in 66 countries working on breakthrough solutions and technologies. In 2017, we invested a total of € 2.1 billion in research and development.
The only exceptions are the United States and Canada. Here we operate as EMD Serono in the Biopharma business, as MilliporeSigma in the Life Science business, and as EMD Performance Materials in the materials business. www.merckgroup.com