| Updated On | : 14-03-2025 |
| Reference No. | : | KMN040343 |
| Job Type | : | Full Time |
| Job Location | : | Mayangone Township , Yangon |
| Salary/Benefits | : | Negotiable |
| For more details | : | 09 88 33 55 893 |
• Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related field.
• Must (5) years of experience in regulatory affairs, compliance, or quality assurance within the pharmaceutical industry.
• Strong Knowledge of Pharmaceutical Regulations & Compliance
• Regulatory Documentation & Submission Management
• Good Manufacturing & Distribution Practices (GMP & GDP)
• Attention to Detail & Accuracy
• Effective Communication & Negotiation with Health Authorities
• Problem-Solving & Strategic Thinking
• Preferred Qualifications (Optional):
• Experience with FDA, EMA, WHO, or other regulatory body submissions.
• Certification in Regulatory Affairs (RAC) is an advantage.
• Knowledge of pharmacovigilance and product safety regulations.
• Regulatory Compliance & Product Registration
• Ensure all pharmaceutical products comply with local and international regulatory requirements.
• Prepare and submit dossiers, regulatory filings, and documentation to health authorities (e.g., FDA, EMA, WHO).
• Manage the registration, renewal, and approval process for new and existing products.
• Maintain up-to-date knowledge of pharmaceutical regulations, guidelines, and industry trends.
• Liaison with Regulatory Authorities
• Act as the primary contact with government health agencies and regulatory bodies.
• Respond to regulatory queries and ensure timely submission of required information.
• Participate in regulatory audits and inspections, ensuring all findings are addressed.
• Compliance with GMP, GDP, and Other Standards
• Ensure adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Clinical Practices (GCP).
• Work closely with quality assurance (QA) and manufacturing teams to ensure compliance.
• Conduct internal regulatory audits to maintain compliance and identify improvement areas.
• Regulatory Strategy & Documentation Management
• Develop and implement regulatory strategies for product approvals and market entry.
• Maintain records of licenses, registrations, permits, and regulatory correspondence.
• Ensure product labels, packaging, and marketing materials comply with legal and regulatory standards.
• Cross-Functional Collaboration & Training
• Work closely with R&D, quality control (QC), marketing, and supply chain teams to align regulatory requirements.
• Train internal teams on regulatory updates, industry standards, and compliance protocols.
• Assist in pharmacovigilance and adverse event reporting as required.
Business : Pharmaceutical Company
Location : Mayangone Township, Yangon
Working hours : 9:00 AM to 5:30 PM
Off Days : Sunday & Gazette Holidays
Ferry provided (Near pick-up point)
* Email your CV (Microsoft Word) to cv@mascotmyanmar.com, describing
“Regulatory Manager - KMN040343” in the Subject of the email.
Email ပို့လျှင် Subject တွင် “Regulatory Manager - KMN040343” ဟု ဖော်ပြပေးပါရန် မေတ္တာရပ်ခံအပ်ပါသည် ။
