Regulatory Affairs Staff

4 days ago

Santo Tomas, Calabarzon, Philippines ARKRAY Full time ₱200,000 - ₱240,000 per year
  • Prepares necessary documents for the approval of application and compliances with government authorities such as PDEA, FDA, BFAD ensuring timely submission.
  • Liaises with FDA and other agencies for product registration and other concerns.
  • Monitors validity of documents required by the business such as Licenses, Certifications, permits etc.
  • Maintains and renew certificates of product registration of existing products.
  • Files amendments/variations with FDA as may necessary.
  • Updates and disseminate information to all concerned department on the latest regulations and circular as need arises.
  • Performs necessary inspection in coordination with Team concerned on matter that may affect transaction with government agencies.
  • Creates and revises Standard Operating Procedures used by the company for operations under Regulatory.
  • Assists in the internal audits or 3rd party audits and closure of audit findings.
  • Conducts training in relations to quality management systems.
  • Assists immediate superior in the continual review of internal processes and procedures.

Job Types: Full-time, Permanent

Pay: Php16, Php20,000.00 per month

Benefits:

  • Additional leave
  • Company Christmas gift
  • Company events
  • Free parking
  • Health insurance
  • On-site parking
  • Opportunities for promotion
  • Paid training
  • Pay raise
  • Promotion to permanent employee

Experience:

  • regulatory affairs: 3 years (Required)

License/Certification:

  • PRC License for Pharmacist (Required)
  • PRC License for Chemist (Required)

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