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
Meet with healthcare professionals (HCPs), key opinion leaders (KOLs), and pharmacists to promote products and strengthen relationships. Develop and execute product marketing plans and annual forecasts. Prepare accurate demand forecasts based on sales data, field insights, and seasonal trends. Train and motivate Medical Representatives/Medical Sale Representatives on product knowledge, sales techniques, and new campaign rollouts. Plan and organize CME events, product launches, doctor group meetings, and promotional campaigns. Design and review promotional tools including visual aids, product brochures, and digital content. Work with Regulatory Affairs for label compliance and product registration. Analyze sales data, prescription trends, and market performance to provide monthly performance reports. Prepare and manage brand marketing budgets.