* Project's objectives: Support to review artwork, PI and prepare the registration dossier for all products in company name change project
* Scope: Support to prepare dossiers as per guidance from RA manager
Reporting directly to: Regulatory Affairs Manager
* Subordinate: NA
* High frequency of interaction: Weekly report
* Working location: Glomed Pharmaceutical Co., Ltd., 35 Tu Do Boulevard, An Phu, Thuan An, Binh Duong.
Core job responsibilities:
* Prepare registration dossier as RA Manager's guidance
* Get product registration plan and assigned task directly from RA Manager
* Prepare variation/ supplementary domestic/ export registration dossiers as requested
* Translate documents from Vietnamese into English and opposite way as requested
* Archive, manage registration dossiers and other dossiers, documents.
Core Skill Requirement
* Organizational, arrangements skills
* Data analysis and processing skills.
* Proficient computer skills
* Writing and presentation skills
* English skill: Enough to search and understand English professional document and prepare English dossier as well as bilingual translation, English communication related to regulatory affairs
Core Trait/Behavior Requirement:
* Teamwork. High adaptation to changes.
MINIMUM EDUCATION REQUIRED
* Graduate or Undergraduate level
* Major in Pharmacist Bachelor
Vietnam > Thuan An : Binh Duong Plant 1
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
|Posted on:||14 Jan 2022|
|Type of job:||Internship|