Regulatory Affairs Assistant

Regulatory Affairs Assistant (30K-35K) (SDG-25451)
<Job Responsibilities>
 Ensure that a company's products comply with the regulations of the regions where they want to distribute them
 Keep up to date with national and international legislation, guidelines and customer practices
 Collect, collate and evaluate scientific data from a range of sources
 Develop and write clear arguments and explanations for new product licenses and license renewals
 Prepare submissions of license variations and renewals to strict deadlines
 Monitor and set timelines for license variations and renewal approvals
 Work with specialist computer software and resources
 Write clear, accessible product labels and patient information leaflets
 Plan and develop product trials and interpret trial data
 Provide strategic advice to senior management throughout the development of a new product
 Undertake and manage regulatory inspections
 Review company practices and provide advice on changes to systems
 Liaise with, and make presentations to, regulatory authorities
 Negotiate with regulatory authorities for marketing authorization
 Specify storage, labeling and packaging requirements.

Workplace Area: BTS Pleonjit, Bangkok
Working Hour: 8:30-17:00 (Mon-Fri)

About the Benefits
Salary: 30,000–35,000THB


About the company
Products: Import & sell pharmaceutical products, and new drug registration, etc.
Business Type: Pharmaceuticals



<Necessary Skill / Experience >
 Thai nationality, Male/Female, age 23-28 years old
 Bachelor’s degree of pharmaceutical or any related field
 Experience as Regulatory Affairs around 1 years
 Have pharmaceutical license
 Good command of English
 Computer literacy (MS Office etc.)

<Preferable Skill / Experience>
 None

Languages skills
English: Conversational Level
Japanese: None

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