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Regulatory Affairs Assistant Manager

(Regulatory and Compliance)

Kalbe Myanmar Co.,Ltd
သံလျင် | ရန်ကုန်တိုင်း
  1 ဦး
Verified This job has been verified by the company as a real job vacancy. ဒီနေ့
လွန်ခဲ့သော4 နာရီ က အလုပ်ခန့်အပ်သူ active ဖြစ်နေခဲ့သည် The recruiter at this company was last active reviewing applications.
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Regulatory Affairs Assistant Manager

(Regulatory and Compliance)

Kalbe Myanmar Co.,Ltd
လွန်ခဲ့သော4 နာရီ က အလုပ်ခန့်အပ်သူ active ဖြစ်နေခဲ့သည် The recruiter at this company was last active reviewing applications.
Myanmar - ရန်ကုန်တိုင်း
Verified This job has been verified by the company as a real job vacancy.

လုပ်သက်အဆင့်

Experienced Non-Manager

အလုပ်အမျိုးအစား

Legal, Risk and Compliance

အလုပ်၏လုပ်ငန်းအမျိုးအစား

ဇီဝနည်းပညာ/ဆေးဝါးထုတ်လုပ်ရေး

အနိမ့်ဆုံး ပညာအရည်အချင်း

Bachelor Degree

အလုပ်ချိန်အမျိုးအစား

Full Time

လုပ်ဆောင်ရမည့်တာဝန်များ

A Big Opportunity for ...

  • Daily Factory Operations: Based on-site at the manufacturing facility to oversee and ensure all daily production activities align with regulatory standards.

  • National Compliance & Coordination: Act as the primary liaison with the Myanmar Food and Drug Administration (FDA) and other local authorities to manage product registrations, renewals, and variations.

  • Product Lifecycle Management: Lead the submission and tracking of regulatory dossiers for new product registrations and ensure timely updates for any product variations based on company needs.

  • International Regulatory Alignment: Coordinate with external regulatory bodies and head office organizations to ensure compliance with international standards for exported products.

  • Cross-Border Collaboration: Work closely with the global head office to harmonize local regulatory strategies with international requirements and corporate policies.

  • Regulatory Intelligence: Stay updated on changes in both domestic and international pharmaceutical laws to ensure the factory remains in full compliance at all times.

ဘယ်သူ့အတွက်လဲ

Expatriate
Repatriate
Male/Female

လိုအပ်သောအရည်အချင်း

  • Minimum of 5 years of professional experience in Regulatory Affairs.
  • Strong expertise in coordinating with the Myanmar FDA and other relevant government officials for product compliance and registration.
  • A Bachelor’s Degree in any field.
  • Demonstrated ability to communicate effectively and maintain professional relationships with local authorities and external stakeholders.
  • Deep understanding of Myanmar’s regulatory landscape and the ability to navigate official government processes efficiently.

ကျွန်တော့်တို့ ဘာတွေကမ်းလှမ်းနိုင်သလဲ

အက်ိဳးအျမတ္

. Ferry Provided (Depend on Ferry way)
. Meal Provided
. Transportation allowance
. Sat Sun and Public holiday off

ထူးခြားချက်များ

. Fun working environment
. International standard
. Make a difference
. Join with dynamic team

အခွင့်အလမ်းများ

. Learn new skills on the job
. Possibility for job training

အလုပ် လျှောက်မည်

OR

လုပ်သက်အဆင့်

Experienced Non-Manager

အလုပ်အမျိုးအစား

Legal, Risk and Compliance

အလုပ်၏လုပ်ငန်းအမျိုးအစား

ဇီဝနည်းပညာ/ဆေးဝါးထုတ်လုပ်ရေး

အနိမ့်ဆုံး ပညာအရည်အချင်း

Bachelor Degree

အလုပ်ချိန်အမျိုးအစား

Full Time

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