Senior Compliance Regulatory Pharmacist

6 days ago

Taguig, National Capital Region, Philippines Insight Connect Solutions Inc. Full time ₱450,000 - ₱600,000 per year

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.

Job Qualifications:

  • 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

Job Types: Full-time, Permanent

Pay: Php30, Php50,000.00 per month

Benefits:

  • Additional leave
  • Company events
  • Opportunities for promotion
  • Paid training
  • Pay raise
  • Promotion to permanent employee

Work Location: In person

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