Regulatory Affair Officer - Medical Products

Pacific-AA Group

ဒဂုံမြို့သစ်ဆိပ်ကမ်း | ရန်ကုန်တိုင်း

ရန်ကုန်တိုင်း

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Regulatory Affair Officer - Medical Products

Regulatory Affair Officer - Medical Products

Pacific-AA Group

ရန်ကုန်တိုင်း

Regulatory Affair Officer - Medical Products

Pacific-AA Group

Myanmar - ရန်ကုန်တိုင်း

ဒဂုံမြို့သစ်ဆိပ်ကမ်း | ရန်ကုန်တိုင်း

24 Jul 2023

လုပ္သက္အဆင့္

Experienced Non-Manager

အလုပ္အမ်ိဳးအစား

Medical, Nursing, Pharmacy

Job Industry

ဆေးဝါးနှင့် ဆေးဘက်ဆိုင်ရာသိပ္ပံ

အနိမ့္ဆံုး ပညာအရည္အခ်င္း

Bachelor Degree

Job Type

Full Time

လုပ္ေဆာင္ရမည့္တာ၀န္မ်ား

A Good 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

လိုအပ္ေသာအရည္အခ်င္း

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

အက်ိဳးအျမတ္

Rewards for over performance

ထူးျခားခ်က္မ်ား

Fun working environment

အခြင့္အလမ္းမ်ား

Learn new skills on the job

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