Regulatory Affairs Executive
en world Thailand
jobsDB ref: JTH300003001211058
Employer Ref. JO-1608-353853
- Filing documents for pre-marketing approval for local distribution and exporting.
- Prepare documents for registration pharmaceutical ingredients or extension use of the products in APAC.
- Ensure labelling compliance and apply a health certificate to Thai FDA Central Office for exporting.
- Filing petitions for amendment usage level of certain pharmaceutical ingredients for a certain types of drug category
- Ensure all regulatory information and guideline are up to date. Review new statement, circulate concerned parties and put new statement in a new standard template
- Review all customer questionnaires and ensure all answers meet company's policy and regulations
- Maintain valid documents in the APAC Regulatory Affairs Extranet
- Regularly train related staff on regulatory compliance and good practice on how to fill in customer questionnaires
- Thai Nationality
- Bachelor degree in Pharmaceutical with at least 2-3 years related working experience
- Dealing with Thai FDA Central Office and customer services team
- Direct experience in pharmaceutical is advantage
- Advance Microsoft Excel
- Excellent English communication skill
- Systematic, well-organized, service minded, proactive, good discipline
For a confidential discussion please call 02-106-8660 and ask to speak to the Nikkei Team.
Your application will be treated with strict confidential.
en world Recruitment (Thailand) Co., Ltd.
Athenee Tower, 12th Floor, Unit 1201-1202
63 Wireless Road, Lumpini, Pathumwan, Bangkok 10330 Thailand
Tel: +66 (2) 106 8600 | Fax: +66 (0) 2654 0901
jobsDB will send your application for review directly to en world Thailand
About en world Thailand
With offices in both Bangkok and Chonburi, we specialise in mid-career and managerial candidates across a broad range of industries. At en world we have consultants with specialised knowledge of specific industries and fields. en world recruits specialist and managerial talent for globally minded companies in the Asia-Pacific region. Established in Thailand in 1999, we believe that our extensive years in the Thai market, helps us guarantee superiors, results driven activities that balance the needs of our client with the career needs of the candidates with whom we work. We were established in Japan in 1999 and have expanded to Australia, India, Singapore, Thailand and Vietnam. With 650 staff representing 20 nationalities in 15 offices, we introduce talent to over 2,800 clients across the Asia Pacific Region. en world is a subsidiary of en-japan Inc., Japan's leading internet-based recruitment solutions provider.