Regulatory Affairs Manager - Health Care Product, Medical Industry: 1 Post (Male/Female)
Pacific Medical Industries Ltd.
2 months ago
- Ensure to Keep up-to-date changes in regulatory legislation and guidelines
- Preparation and submission of required documents on time to FDA (Dossier, specification on Raw Material, Packaging Materials, and Finished Goods, Product design, samples, and all other relevant documents) to achieve the registration and renewal approvals as per schedule timeline.
- Preparation, review and submission of applications for Import Recommendations and Import licenses with relevant govt regulatory.
- Preparation, review and submission of Chemical licenses, manufacturing licenses and other related applications to the relevant regulatory.
- Follow up for the approval from government regulatory and provide regular status updates to the management team and proactively coordinate and work closely with all relevant internal and external parties to resolve any issues to get the results out timely.
- Prepare and host the regulatory and government agency and their auditors on site visit and ensure all audits findings and follow up activates and actions items are being carried out timely by coordinating with all relevant departments.
- Keep update time to time the site team and management on any new regulations and updates from Regulatory agencies.
- Maintain confidentiality on the data and all company information and observations by the regulatory agencies.
- Follow site GMP procedures and documentation.
- 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.
- BDS, B.N.Sc/B.Med.Tech 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 firstname.lastname@example.org.