Licensed Pharmacist

4 days ago

Taguig, Philippines Insight Connect Solutions Inc. Full time

On-site - Taguig 1-3 Yrs Exp Bachelor Full-time

Overview

On-site position in Taguig requiring 1-3 years of relevant experience. Candidate should hold a bachelor’s degree. Fresh graduates may apply as applicable for certain regulatory roles.

Responsibilities
  • 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.
Qualifications
  • 2-3 years experience with FDA & BAI regulatory application
  • Fresh Graduates are welcome to apply
  • Licensed Pharmacist required
  • Must be willing to work on-site at BGC Taguig
  • Can start ASAP
Government Mandated Benefits
  • Maternity & Paternity Leave, Sick Leave, Solo Parent Leave, Vacation Leave
Professional Development
  • Job Training
Working Location

24th, The Philippine Stock Exchange, Inc.. PSE Tower, 5th Avenue corner 28th Street, BGC 1634, Taguig, Philippines

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