Job Description

• Ensure to Keep up-to-date changes in regulatory legislation and guidelines
• Preparation and submission of required documents on time to FDA (Medical Devices Section, Food Section and Cosmetic Section) to achieve the registration approval as per schedule timeline.
• Ensuring to double check the requirements before submitting to local authority to avoid any delay in submission.
• Manage the activities of Regulatory Affairs department and ensuring the implementation of appropriate and effective regulatory strategies by providing training, supervision and motivation to improve the department performance.
• Ensuring that goods and services are obtained at appropriate cost level and will meet regulation agencies, suppliers and manufacturers satisfaction.
• Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil respective regulatory and quality standards
• Plan, undertake and oversee product trials and regulatory inspections for renewal products
• Develop and maintain good relationship with local FDA and business partner (suppliers and Manufacturers)
• Review and report overall registration approval status to the management
• To make sure to get the FDA approval on time to prevent delay in importation, custom clearing and releasing into sales.
• Thorough understanding and demonstrated ability to apply regulatory guidelines and regulations to successful dossier preparation, submission and maintenance
• Strong initiation, planning and organizational skills
• Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes with business partner
• Attention to details and ability to appropriately assess risks
• Team-player, able to positively influence team members
• Proactive, quick learner and independent worker able to effectively multi-task in a high-pressure environment and follow issues through to conclusion
• Ability to build healthy relationship with government stakeholders

Job Requirement

• MBBS/B.Pharm
• BDS, B.A.Sc/MedTech is preferable
• Minimum 5 years’ experience as a regulatory affairs manager in pharmaceutical industry
• Strong Knowledge of local and international pharmaceutical legislation, relevant guidelines, procedures and Requirements
• Fluency in both Myanmar and English languages
• Through understanding and demonstrated ability to apply regulatory guidelines and regulation to successful dossiers preparation, submission and maintenance
• Strong initiation, planning and organizational skills
• Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes with business partner
• Attention to details and ability to appropriately assess risks
• Team-player, able to positively influence team members
• Proactive, quick learner and independent worker able to effectively multi-task in a high-pressure environment and follow issues through to conclusion
• Ability to build healthy relationship with government stakeholder

How to Apply: Please apply to hr.recruitment@pacific-aa.com.