Regulatory Affairs Intern

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.

• Trustworthiness.

• Diligence.

MINIMUM EDUCATION REQUIRED

• Graduate or Undergraduate level

• Major in Pharmacist Bachelor

• Attractive Allowance

• Training & Development

• 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.