Regulatory Compliance:

• Ensure company operations and products comply with the rules and regulations of the Philippine FDA. -
• Monitor updates and advisories issued by the FDA and ensure immediate company-wide implementation.
• Prepare and submit compliance reports and documentation to the FDA.

Licensing and Registration

• Oversee the application and renewal of FDA licenses such as LTO (License to Operate), CPR (Certificate of Product Registration), and other necessary permits for pharmaceuticals, cosmetics, food, and medical devices. - Maintain up-to-date records of all regulatory filings and certificates.

Audit and Inspection Handling:

• Prepare the company for routine and spot inspections by FDA officers. - Serve as the point person during FDA audits and respond to FDA findings or notices

Documentation and Record Keeping

• Maintain comprehensive and accurate documentation of all compliance-related activities. - Ensure traceability and document integrity for all FDA-regulated products.

Internal Training and Policy Development

• Educate staff and departments on FDA regulations and compliance protocols.
• Develop internal SOPs (Standard Operating Procedures) based on regulatory guidelines.

Adverse Event and Recall Management

• Monitor and report adverse drug reactions or product complaints to the FDA as required.
• Coordinate product recalls in case of FDA-mandated withdrawals or safety issues.

Liaison with Regulatory Authorities:

• Communicate effectively with FDA personnel and other government agencies. - Ensure timely submission of queries, appeals, and supporting documents.

• 2-3 years experience with FDA & BAI regulatory application
• Fresh Graduates are welcome to apply
• Licensed Pharmacist required
• Good communication skills
• Must be willing to work on-site at BGC Taguig
• Can start ASAP