Job Description

• Product Approvals and Registrations: 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. To make sure to receive all the necessary approvals on time.
• Regulatory Strategy Development: Creating and implementing strategies to navigate regulatory requirements effectively, considering both short-term needs and long-term goals of the organization.
• Interaction with Regulatory Authorities: Serving as the primary point of contact for communication and interaction with regulatory agencies, addressing inquiries, providing information, and ensuring timely responses to requests.
• Regulatory Intelligence: Staying up to date with changes in regulations, industry trends, and competitive landscape to inform decision-making and maintain compliance.
• Risk Assessment and Management: Identifying potential risks related to regulatory compliance and making informed decisions to mitigate these risks while minimizing impact on business operations.
• Cross-Functional Collaboration: 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.
• Labeling and Packaging Compliance: Overseeing the accuracy and compliance of product labeling, packaging, and promotional materials to ensure they adhere to regulatory guidelines.
• Quality Systems: Ensuring that the organization's quality systems, documentation, and processes align with regulatory expectations, including Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
• Clinical Trials Support: 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.
• Post-Market Surveillance: Monitoring and reporting adverse events, product complaints, and other post-market surveillance activities as required by regulations.
• Training and Education: Conducting training sessions and workshops to educate internal teams about regulatory requirements, changes, and best practices.
• Audit and Inspection Readiness: Preparing the organization for regulatory audits and inspections, ensuring that all necessary documentation and processes are in place.
• Regulatory Documentation Management: Maintaining accurate and organized records of all regulatory-related documents and submissions.
• Advisory Role: Providing expert advice to senior management regarding regulatory implications of business decisions and strategies.
• Regulatory Compliance: Ensuring that the organization's products, processes, and operations are in full compliance with relevant laws, regulations, and guidelines set forth by regulatory authorities.
• Overall, the Regulatory Affairs Officer plays a pivotal role in safeguarding the organization's compliance with regulatory standards, maintaining product quality and safety, and supporting business growth within a highly regulated environment.

Job Requirements

• MBBS or B.Pharm or BDS or B.N.Sc or B.Med.Tech  
• Minimum five years’ experience as a regulatory affairs officer in the pharmaceutical and/or medical device industry (Experience as an RA Officer in a Pharmaceutical Manufacturing environment is required for the position of Pharma Factory RA Officer)
• 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, presentations, and communication.
• Web Research Skills and Proficiency in using virtual meeting and communication tools
• Strong 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 all the stakeholders

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