Job Description

• Product Approvals and Registrations: Manage the submission of applications, documentation, and data to obtain the necessary approvals, licenses, and registrations for the organization’s products. Ensure that all required approvals are received on time to avoid delays in product marketing and sales.
• Regulatory Strategy Development: Develop and implement strategies to navigate regulatory requirements effectively, balancing the organization's short-term needs with its long-term goals.
• Interaction with Regulatory Authorities: Serve as the primary point of contact for communication with regulatory agencies. Address inquiries, provide requested information, and ensure timely responses to regulatory requests.
• Regulatory Intelligence: Stay updated on changes in regulations, industry trends, and the competitive landscape to inform decision-making and maintain ongoing compliance.
• Risk Assessment and Management: Identify potential regulatory risks and make informed decisions to mitigate these risks, minimizing their impact on business operations.
• Cross-Functional Collaboration: Work closely with internal departments such as R&D, quality assurance, manufacturing, marketing, and legal to ensure alignment with regulatory requirements across all organizational functions.
• Labeling and Packaging Compliance: Oversee the compliance of product labeling, packaging, and promotional materials to ensure they adhere to all applicable regulatory guidelines.
• Quality Systems: Ensure the organization’s quality systems, documentation, and processes meet regulatory expectations, including Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
• Clinical Trials Support: Provide guidance on the preparation and submission of regulatory documents for clinical trials, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
• Post-Market Surveillance: Monitor and report adverse events, product complaints, and other post-market activities as required by regulatory bodies.
• Training and Education: Conduct training sessions and workshops to educate internal teams about regulatory requirements, updates, and best practices.
• Audit and Inspection Readiness: Prepare the organization for regulatory audits and inspections, ensuring all required documentation and processes are in place.
• Regulatory Documentation Management: Maintain organized and accurate records of all regulatory-related documents and submissions.
• Advisory Role: Provide expert advice to senior management regarding the regulatory implications of business decisions and strategies.
• Regulatory Compliance: Ensure the organization's products, processes, and operations are fully compliant with relevant laws, regulations, and guidelines set by regulatory authorities.

Overall, the Regulatory Affairs Officer plays a crucial role in ensuring the organization remains compliant with regulatory standards, safeguarding product quality and safety, and supporting business growth within a highly regulated environment.

Job Requirements

• Educational Qualifications: MBBS, B.Pharm, BDS, B.N.Sc, or B.Med.Tech
• Experience: Minimum of five years' experience as a regulatory affairs officer in the pharmaceutical and/or medical device industry. (Experience as a Regulatory Affairs Officer in a pharmaceutical manufacturing environment is required for the Pharma Factory RA Officer role)
• Regulatory Knowledge: Strong understanding of local and international pharmaceutical and/or medical device legislation, relevant guidelines, procedures, and requirements.
• Language Proficiency: Fluency in both Myanmar and English.
• Technical Skills: Proficient in using Microsoft Word, Excel, PowerPoint, and Outlook for documentation, data analysis, presentations, and communication.
• Research and Tools: Strong web research skills and proficiency in using virtual meeting and communication tools.
• Organizational Skills: Excellent planning, organizational, and initiation skills.
• Communication Skills: Outstanding written and oral communication skills, with the ability to influence others and negotiate successful outcomes with business partners.
• Attention to Detail: Keen attention to detail and the ability to assess risks appropriately.
• Teamwork: Strong team player, capable of positively influencing team members.
• Proactive and Independent: Self-starter, quick learner, and able to work independently while effectively managing multiple tasks in a high-pressure environment and following through to completion.
• Relationship Building: Ability to build and maintain healthy relationships with all stakeholders.

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