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Regulatory Affairs Assistant Yangon

DKSH ( Myanmar ) Ltd.

DKSH ( Myanmar ) Ltd. Yangon Burma

1 month ago

• To handle all RA activity for Drug Registration and relating issue
• Implementing on getting the required product license for drug
• Arrangement on renewal registration in time without impact on business
• Consultation with clients and internal teams on the 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 on-going process and pending issues if required
• Preparing and submission of financial advances and claims internally and externally
• Reviewing and management on Regulatory process and system
• Informing the external clients and internal depts. about update procedure, guideline or regulation
• Implementing appointments and hosting local authority for meetings or inspection
• Cooperation in internal and external audit related to RA and PV with CAPA
• Acting as liaison between client and government authority in RA and PV issue
• Any Degree holder in... Science, Chemistry, Pharmacy, or related disciplines. (B. Pharm is preferred)
• 1 Year of experience in the regulatory field is preferable.
• Demonstrate good working knowledge, comprehension, and applications of local regulations. (Nice to have; Familiar with chemical ingredients)
• Demonstrate proficiencies in office productivity tools (e.g. Excel, Word, and PowerPoint)
• Demonstrate fluency in the local language and in English, both written and spoken.
• Able to travel when the job requires.
• Must haves Diligent, Self-motivative, and collaborative

-According to the company policy
Yangon Myanmar (Burma)

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