Regulatory Affairs Manager

Responsibilities

• Ensure to Keep up-to-date changes in regulatory legislation and guidelines
• Preparation and submission of required documents on time to the FDA (Dossier, specification on raw materials, packaging materials, finished goods, product design, samples, and all other relevant documents) to achieve registration and renewal approvals as per schedule timeline
• Ensure to double-check the requirements before submitting to the local authority to ensure timely submission
• Manage the activities of the Regulatory Affairs department and ensure the implementation of appropriate and effective regulatory strategies by providing training, supervision, and motivation to improve the department's performance
• Ensuring that goods and services are obtained at appropriate cost levels and will meet regulation agencies, suppliers, and manufacturers' satisfaction
• Ensure that quality standards are met and the deliverables meet strict deadlines and fulfill respective regulatory and quality standards
• Planned, undertook, and oversaw product trials and regulatory inspections for renewal products
• Develop and maintain good relationships with local FDA and business partners (suppliers and manufacturers)
• Review and report overall registration approval status to the management
• To ensure getting the FDA approval on time to prevent delay in the importation, custom clearing, and release into sales
• Thorough understanding and demonstrated ability to apply regulatory guidelines and regulations to successful dossier preparation, submission, and maintenance

Job Requirements:

Required Qualifications And Skils

• MBBS, M. Pharm., B. Pharm., BDS, B. N.Sc., B. Med. Tech are preferable
• Minimum 5 years’ experience as a regulatory affairs manager in the pharmaceutical industry
• Strong Knowledge of local and international pharmaceutical legislation, relevant guidelines, procedures, and requirements
• Fluency in both Myanmar and English languages
• Intense initiation, planning, and organizational skills
• Outstanding written and oral communication skills, with the ability to influence others and negotiate successful outcomes with business partner
• Attention to detail 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 relationships with government stakeholders

Working Time:

9:00 AM ~ 5:00 PM

Monday ~ Friday

Saturday & Sunday closed

Job Benefits:

Employer details:

A Successful Multinational Distribution Company

Salary:

Up to 2,000 USD

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