Regulatory Affairs Specialist – 1,000,000 ++ – Korea Company – 2 Posts

Team 21 (VAC)
Job Overview

Job Location: Kyauktada Townhsip

Type of Business/Product: Trading Industry/Medical Device and Pharmaceutical Products

Gender: Male/Female (2)

 Job Ref No.: 21P1499

Salary: 1,000,000 ++ Kyats

 

 Job Requirements

  • Any Bachelor Degree holder in Science, preferably B.Pharm.
  • Prefer 1-2 years’ experience in related field.
  • Computer literacy, Microsoft excel & Mail Accounting knowledge.
  • Honest and work hard, Strong communication with different function.
  • Strong interpersonal, negotiation and communication skills.

 

Job Descriptions

Operation

  • Implementing on getting required product license for drug
  • Arrangement on renewal registration in time without impact on business
  • Consultation with clients and internal teams on regulatory process with requirements
  • Arrangement on importation of drug sample, DIAC, one time permit and lot release for commercial
  • Following up with local authority for ongoing process and pending issue if required
  • Preparing and submission of financial advances and claims internally and externally

 

Reporting

  • Submission of daily report for registration activity of respective clients to immediate supervisor
  • Submission of status reporting and discussion with client on registration process and requirement
  • Updating regulatory submission and achievement monthly

Management

  • Reviewing and management on Regulatory process and system
  • Archiving the documents and inventory in good documentation practice

 

Coordination

  • Informing the external clients and internal depts. about update procedure, guideline or regulation
  • Implementing on appointment and hosting local authority for meeting or inspection
  • Cooperation in internal and external audit related to RA and PV with CAPA
  • Advising on importation, storage and distribution process based on existing regulation and guideline
  • Acting as liaison between client and government authority in RA and PV issue
  • Align with BD, Client Management, ISC, Sales and Marketing, logistic etc. for purchase order, importation and stock balance.

 

Working Hours: 8:00 AM to 5:00 PM

Holidays:  Saturday & Sunday, Public Holidays

How to Apply: Please email to cv@vacjobsearch.com with your Microsoft Word CV file and job title and job ref no. in subject line.

Hotline01-8395921,09-765395921

 

Job Detail
  • Offerd Salary1,000,000 - 1,500,000 MMK
  • Career LevelMid-level Management
  • Experience2 Years
  • GenderBoth
  • INDUSTRYHealth, Pharmaceuticals, and Biotech
  • QualificationBachelor
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