Job Description
Regulatory Affairs Manager at one of the Pharmaceutical Companies in Pyin Oo Lwin
Lead the development and execution of regulatory strategies for pharmaceutical and medical devices, ensuring timely market access and regulatory compliance across all regions
Up to 1,500,000 MMK plus other allowances and benefits
The Role
Responsible for preparing and submission of regulatory documents including FDA, DRC and product registration process
About the Company
The company maintains a significant presence in Yangon and supplies pharmaceutical and medical devices
Description
Manage the regulatory strategy and submission process for new brand extensions or line extensions of existing products, ensuring that all necessary regulatory approvals are obtained
Ensure compliance with all relevant regulatory requirements for the company's portfolio of products, including pharmaceutical, medical devices, and combination products in international markets
Work closely with R&D, manufacturing, quality, and commercial teams to provide regulatory guidance and support throughout the product development cycle
Manage and ensure compliance with Drug Information and Approval Compliance (DIAC) requirements for all products. Maintain proper records and documentation for all registered products and variations
Requirements
Bachelor’s degree in science, chemistry, pharmacy or other related field
Over 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry
Strong understanding of the regulatory requirements for drug registration, packaging variations, and changes in product claims, indications, and labeling
In-depth knowledge of global regulatory requirements (FDA, WHO, and local regulations in key markets)
Familiarity with Drug Information and Approval Compliance (DIAC) and regional health authority portals
Strong problem-solving skills, with the ability to proactively identify regulatory challenges and develop effective solutions
Benefits
Competitive Allowances
Career Growth Opportunities
Opportunities for advancement into senior financial leadership roles within the organization