(Position Filled) Regulatory Affairs Manager - Cosmetic, Medical Device, Drug: 1 Post (Male/Female)
AA Medical Products Ltd.
Yangon, Myanmar
Full Time
Posted
1 year ago
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.