Pharmacist

RoymedSeth Pharmaceutical Inc.; San Fernando; On-site; PHP 350,000 - 700,000; Full time

Job summary

RoymedSeth Pharmaceutical Inc. is seeking a regulatory affairs professional in the Philippines to secure and renew licenses and registrations essential for product approvals and market access.

The role covers tracking licenses, assisting with FDA inspections, and providing regulatory support for new product development in a compliant, timely manner.

Qualifications

• Regulatory documentation diligence
• Attention to detail in license management
• Organizational skills for tracking licenses

Responsibilities

• Secure and renew License to Operate (LTO) and other regulatory licenses
• Prepare and submit applications for initial and renewal product registration with the FDA
• Monitor and maintain the validity of CPRs, CGMPs, LTOs, and other regulatory certificates
• Coordinate regulatory requirements for government bidding and technical documentation
• Monitor the status of applications with regulatory agencies
• Maintain a systematic tracking system for licenses, certificates, and expiration dates
• Assist during FDA inspections and compliance audits
• Provide regulatory support for new product development
• Ensure compliance with applicable regulatory requirements and standards

Job description

KEY RESPONSIBILITIES

Secure and renew License to Operate (LTO) and other regulatory licenses

Prepare and submit applications for initial and renewal product registration with the Food and Drug Administration (FDA)

Monitor and maintain the validity of CPRs, CGMPs, LTOs, and other regulatory certificates

Coordinate regulatory requirements for government bidding and technical documentation

Monitor the status of applications with regulatory agencies

Maintain a systematic tracking system for licenses, certificates, and expiration dates

Assist during FDA inspections and compliance audits

Provide regulatory support for new product development

Ensure compliance with applicable regulatory requirements and standards