Regulatory Affairs Executive
LP & Associates' client
Ho Chi Minh City
Posted
71 months ago
Position
Regulatory Affairs Executive
Function
Regulatory Affairs
Location
Travel between HCM & Binh Duong
Reporting to
Regulatory Affairs Supervisor
RESPONSIBILITIES
Get product registration plan and assigned task directly from RA Manager.
Percentage of unpassed/ rejected dossiers.
Progress of registration dossier (except for delays from relevant departments).
Refer to the products which have similar dosage form, strength, packing form, package material and shelflife.
Refer to reliable documents from official sources to find out clinical, pharmacology, pharmacokinetic characteristics… of active ingredient and product.
Prepare leaflet with bilingual Vietnamese-English content.
Prepare new domestic/ export drug registration dossiers according to current technique guideline and regulation.
Prepare variation/ supplementary domestic/ export registration dossiers as requested.
Prepare renewal domestic/ export drug registration dossiers periodically.
Translate documents from Vietnamese into English and opposite way as requested.
Search and update information about Drug/ Food supplement regulation as well as regulatory affairs.
Ensure reliable and updated source
Follow up, receive information/ feedback from Drug Administration of Vietnam (DAV), Vietnam Food
Administration (VFA) – Ministry of Health (MOH) about registration supplementary dossier, Decision of
Visa number Issuance as well as approval official letter for changing/supplement.
Understand information/ request and disseminate fully to relevant departments.
Supplement as requests of authorities about drug/ food supplement registration fully and on time.
Update regulation/ decision/ circular/ official letter related to product registration, manufacturing and circulation.
Full information source, organized scientifically to search easily.
Participate in preparing/ updating SOPs, forms and other documents related to regulatory affairs.
Archieve, manage registration dossiers and other dossiers, documents..
REQUIREMENTS
• Pharmacist Bachelor.
• At least 2 years experience at equivalent position.
• Organizational, job arrangements skills.
• Data analysis and processing skills.
• Writing and presentation skills.
• Proficient computer skill.
• English skill: Enough to search and understand English professional document and preprare English dossier as well as bilingual translation, English communication related to regulatory affairs.
Fields marked with a * are required.
Company Size:
over 1000 employees
Industry:
Pharmaceutical
Job Category:
Pharmaceuticals
Job Type:
Full Time
Location:
Ho Chi Minh City
Desired skills:
English
Job Level:
Executive
Preferred language to receive applications:
English
Company address:
144 Phung Van Cung Str, Ward 4, Phu Nhuan Dist, HCMC
Contact name:
Ms. Nhu Thuyen
Phone number:
Tel: (+8428) 22532930 , Ext : 604
Email address:
phuong.lan.nguyen@natopjobs.com.vn
recruitment@natopjobs.com.vn
lanphuong@lp-a.com.vn
nhuthuyen@lp-a.com.vn