Merck Ltd.

Regulatory Affairs Specialist (1 year contract)

Merck Ltd.
Salary provided
Posted on 09 Mar 2021

Regulatory Affairs Specialist (1 year contract)

Merck Ltd.

Job Highlights

  • Regulatory Affairs
  • Pharmaceutical Products
  • 1 years Contract

Job Description

  • 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-years relevant work experience in RA field, including Health Authority Interaction  

  • Relevant scientific backgroundBachelor’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 

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
Not Specified
Job Type
Part Time, Temporary
Company Website

Company Overview

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

Additional Company Information

Benefits & Others
Five-day work week, Flexible working hours, Life insurance, Medical insurance, Work from home