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Job Summary

The Regulatory Affairs Manager is responsible for overseeing all regulatory activities related to pharmaceutical products and food supplements. This role ensures full compliance with Myanmar FDA regulations, manages product registrations, coordinates with clients and authorities, and leads the regulatory team to achieve timely and accurate submissions.

Key Responsibilities

•    Manage product registration, renewal, and variation processes in accordance with Myanmar FDA guidelines

•    Prepare, compile, and submit ACTD dossiers for pharmaceutical products

•    Handle regulatory submissions for food supplements

•    Liaise with Myanmar FDA to address queries, deficiencies, and follow-ups

•    Ensure all submissions meet regulatory requirements and timelines

•    Review and verify completeness and accuracy of all regulatory documents

•    Ensure compliance of labeling and packaging with regulatory standards

•    Maintain proper documentation systems for audit readiness

•    Keep up to date with regulatory changes and ensure internal compliance

•    Communicate with international clients to request and collect necessary regulatory documents

•    Follow up with stakeholders to ensure timely submission and approvals

•    Coordinate with import agencies and relevant parties for smooth processing

•    Monitor import processes and ensure timely product clearance

•    Prepare and review import-related documentation in line with regulatory and customs requirements

•    Support regulatory compliance throughout the product lifecycle

•    Lead and supervise the regulatory affairs team

•    Assign tasks, monitor progress, and ensure timely completion of work

•    Provide training and guidance on regulatory requirements and updates

•    Review team outputs to ensure quality, accuracy, and compliance

Qualifications & Requirements

•    Bachelor of Pharmacy (B.Pharm) or related medical degree

Minimum 5–8 years of experience in regulatory affairs (pharmaceuticals and/or supplements)

•    Strong knowledge of Myanmar FDA regulations and submission processes

•    Proven experience in client coordination and document handling

•    Good communication skills in English (written and verbal)

Strong attention to detail and ability to meet deadlines

•    Leadership or supervisory experience is preferred

Key Competencies

•    Regulatory knowledge and compliance expertise

•    Leadership and team management

•    Communication and stakeholder coordination

•    Problem-solving and critical thinking

•    Time management and organizational skills