Job offer: Senior Regulatory Affairs Officer

Responsibilities

• Managing the submission of applications, documentation, and data to obtain necessary approvals, licenses, and registrations for the organization's products to be legally marketed and sold without any delays
• Creating and implementing strategies to navigate regulatory requirements effectively, considering both short-term needs and long-term goals of the organization
• Serving as the primary point of contact for communication and interaction with regulatory agencies, addressing inquiries, providing information, and ensuring timely responses to requests
• Staying up to date with changes in regulations, industry trends, and competitive landscape to inform decision-making and maintain compliance
• Identifying potential risks related to regulatory compliance and making informed decisions to mitigate these risks while minimizing impact on business operations
• Collaborating with internal departments such as R&D, quality assurance, manufacturing, marketing, and legal to ensure that all aspects of the organization are aligned with regulatory requirements
• Overseeing the accuracy and compliance of product labeling, packaging, and promotional materials to ensure they adhere to regulatory guidelines
• Ensuring that the organization's quality systems, documentation, and processes align with regulatory expectations, including Good Manufacturing Practices (GMP) and Quality Management Systems (QMS)
• Providing guidance and assistance in the preparation and submission of regulatory documents required for clinical trials, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications
• Monitoring and reporting adverse events, product complaints, and other post-market surveillance activities as required by regulations
• Conducting training sessions and workshops to educate internal teams about regulatory requirements, changes, and best practices
• Preparing the organization for regulatory audits and inspections, ensuring that all necessary documentation and processes are in place
• Maintaining accurate and organized records of all regulatory-related documents and submissions
• Providing expert advice to senior management regarding regulatory implications of business decisions and strategies
• Ensuring that the organization's products, processes, and operations are in full compliance with relevant laws, regulations, and guidelines set forth by regulatory authorities

Required Qualifications & Skills

• MBBS or B.Pharm or BDS or B.N.Sc or B.Med.Tech  
• Minimum 5 years’ experience as a regulatory affairs officer in the pharmaceutical or medical device industry
• Strong knowledge of local and international pharmaceutical and/or medical device legislation, relevant guidelines, procedures, and requirements
• Fluency in both Myanmar and English languages
• Proficiency in using applications such as Word, Excel, PowerPoint, and Outlook for documentation, data analysis, and presentations
• Web research skills and proficiency in using virtual meeting and communication tools
• Outstanding written and oral communication skills, with the ability to influence others and negotiate successful outcomes with business partner
• Strong initiation, planning, and organizational skills
• Attention to detail and ability to appropriately assess risks
• 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 all the stakeholders