Location : Sukhumvit 62
Job Description :
-Plan and manage product registration; dossier preparation, dossier review and variation submission for both domestic and other countries
-Responsible for compliance with related regulation e.g. manufacturing license, advertising
-Coordinate with other departments and external agency on regulatory document
-Provide professional recommendations and information on relevant regulations to other departments
-Monitor changes in the regulatory environment and keep up to date with regulatory announcement to support and advice management team
Initiate and continuously develop the process improvement of regulatory affairs department
-Responsible for managing workload, skill-development, coaching and performance feedback of team members
-Participate in other assigned projects of the company
General Qualifications :
Male or Female, aged 30-45 years old
Bachelor’s Degree or higher in Pharmacy/Pharmaceutical
Minimum 5 years experience in regulatory affairs (RA) in pharmaceutical industry or related fields
Well-experienced in coordinating with the FDA.
Good command of English
Able to work as a team with positive attitude and open minded
Holding Pharmacy license plus 5,000 Baht /month
Interested candidate, please send your resume and expected salary to us by Email : rachada@tpdrug.com
Contact: Khun Rachada (Goy)
Time: 8.30 am-17.00 pm
Office Number : 02-020-8585 ext. 2110 Mobile : 064-241-9078
Website : http://www.tpdrug.com
T.P. Drug Laboratories (1969) Co., Ltd.