| Posted | : 01-08-2025 |
| Reference No. | : | NSN10847 |
| Job Type | : | Full Time |
| Job Location | : | Kamayut Township , Yangon |
| Salary/Benefits | : | Negotiable |
| For more details | : | 09 456 882 995 |
• Bachelor's degree in Pharmacy, or related field.
• Proficient in Microsoft Office (Word, Excel, Powerpoint).
• Experience working with multinational pharmaceutical companies.
• Minimum three years of experience in regulatory affairs, specifically with FDA. Proven track record in drug registration, import licenses, and regulatory compliance in Myanmar.
• Experience working with multinational pharmaceutical companies.
• Ensure all product documentation (e.g., COA, GMP, stability data) meets FDA standards.
• Support post-approval regulatory activities (variations, renewals, recalls if needed).
• Monitor regulatory updates and implement necessary changes.
• Strong understanding of Myanmar FDA guidelines, ASEAN regulatory frameworks, and GMP.
• Excellent communication skills (reading, writing, listening, speaking) in English & Burmese and negotiation skills.
• Detail-oriented with strong analytical and documentation skills.
• Familiarity with e-submission processes for FDA.
• Knowledge of ACTD guidelines and WHO GMP.
• Prepare, review, and submit drug registration dossiers to the FDA for approval. Ensure compliance with Myanmar FDA regulations, guidelines, and documentation requirements.
• Track application status, respond to queries, and follow up for timely approvals.
• Obtain necessary import permits, licenses, and renewals for pharmaceutical products.
• Ensure compliance with labeling, packaging, and storage regulations.
• Maintain updated knowledge of changes in Myanmar FDA policies.
• Act as the primary contact between the company and FDA.
• Coordinate inspections, audits, and regulatory meetings as required.
• Maintain accurate records of regulatory submissions, approvals, and correspondence.
Business : Pharmaceutical Company
Location : Kamayut Township, Yangon
Working Hours : 9:00AM to 5:30 PM
Off Days : Sunday & Gazette Holidays
Benefits : Lunch Provided & Other Allowance
* Email your CV (Microsoft Word) to cv@mascotmyanmar.com, describing
“Regulatory Affairs Officer - NSN10847” in the Subject of the email.
Email ပို့လျှင် Subject တွင် “Regulatory Affairs Officer - NSN10847” ဟု ဖော်ပြပေးပါရန် မေတ္တာရပ်ခံအပ်ပါသည် ။
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Bahan Township - Yangon
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700,000 ~ 800,000 + Transportation Allowance
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700,000 ~ 800,000 + Transportation Allowance
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Hlaing Thar Yar Township - Yangon
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250,000
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Pazundaung Township - Yangon
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Pazundaung Township - Yangon
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Mayangone Township - Yangon
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