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Regulatory Affair Officer - Medical Products

Pacific-AA Group
Dagon Myothit (Seikkan) | Yangon
Verified This job has been verified by the company as a real job vacancy.
24 Jul 2023
Recruiter active 6 days ago The recruiter at this company was last active reviewing applications.
Yangon
Verified
Recruiter active 6 days ago The recruiter at this company was last active reviewing applications.
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Regulatory Affair Officer - Medical Products
Pacific-AA Group, Dagon Myothit (Seikkan) | Yangon

Regulatory Affair Officer - Medical Products

Pacific-AA Group
Yangon

Regulatory Affair Officer - Medical Products

Pacific-AA Group
Recruiter active 6 days ago The recruiter at this company was last active reviewing applications.
Myanmar - Yangon
Verified This job has been verified by the company as a real job vacancy.
Dagon Myothit (Seikkan) | Yangon
24 Jul 2023
Verified
Recruiter active 6 days ago The recruiter at this company was last active reviewing applications.

Experience level

Experienced Non-Manager

Job Function

Medical, Nursing, Pharmacy

Job Industry

Pharmaceutical/Life Sciences

Min Education Level

Bachelor Degree

Job Type

Full Time

Job Description

A Big Opportunity for ...

  • Ensure to follow up with NPT regulatory staff relating to pharmaceutical registration rules and regulation changes and report promptly to Regulatory Manager.
  • Ensure timely preparation and compilation of administrative documents and Dossiers as per the FDA guidelines and seek confirmation approval from the Manager.
  • Prepare and review the application for Active Pharmaceutical Ingredient (API), Reference Standard (RS), excipient, chemical, and restricted chemicals and seek confirmation approval from Manager.
  • Follow up with the pharmaceutical registration, API, RS, excipient, chemical, and restricted chemical with NPT regulatory staff to avoid delay in achieving IR and DRC approval on time.
  • Prepare samples for FDA submission.
  • Keep up-to-date on the registration process status records and report to the manager daily.
  • Ensure keeping proper record on handover of document to respective departments and entities.
  • Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
  • Any other Regulatory Affairs related activities

Open To

Male/Female

Job Requirements

  • Relevant degrees such as Chemistry, physics, biochemistry, pharmacy, applied sciences
  • Minimum experience of two years and above in a related field
  • Active and participated in all jobs respective with the team
  • Good communication skills are required to communicate with related internal and government departments.
  • Basic knowledge of local regulatory affairs rules and regulation
  • Time management and well organize skills are key factors in the regulatory affairs department for all the registration processes are on track.

What We Can Offer

Benefits

Rewards for over performance

Highlights

Fun working environment

Career Opportunities

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Experience level

Experienced Non-Manager

Job Function

Medical, Nursing, Pharmacy

Job Industry

Pharmaceutical/Life Sciences

Min Education Level

Bachelor Degree

Job Type

Full Time

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