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Regulatory Affairs Assistant Manager

(Regulatory and Compliance)

Kalbe Myanmar Co.,Ltd
Thanlyin | Yangon
  1 Post
Verified This job has been verified by the company as a real job vacancy. Today
Recruiter active3 hours ago The recruiter at this company was last active reviewing applications.
Yangon
Verified
Recruiter active3 hours ago The recruiter at this company was last active reviewing applications.
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Regulatory Affairs Assistant Manager

Kalbe Myanmar Co.,Ltd
Yangon
Apply Here

Regulatory Affairs Assistant Manager

(Regulatory and Compliance)

Kalbe Myanmar Co.,Ltd
Recruiter active3 hours 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.
Thanlyin | Yangon
  1 Post
Today
Verified This job has been verified by the company as a real job vacancy.
Recruiter active3 hours ago The recruiter at this company was last active reviewing applications.
Apply Here

Experience level

Experienced Non-Manager

Job Function

Legal, Risk and Compliance

Job Industry

Biotechnology/Pharmaceuticals

Min Education Level

Bachelor Degree

Job Type

Full Time

Job Description

An Excellent 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.

Open To

Foreigner (Expatriate)
Repatriate
Male/Female

Job Requirements

  • 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.

What we can offer

Benefits

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

Highlights

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

Career Opportunities

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

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Experience level

Experienced Non-Manager

Job Function

Legal, Risk and Compliance

Job Industry

Biotechnology/Pharmaceuticals

Min Education Level

Bachelor Degree

Job Type

Full Time

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