Documentation and Regulatory Officer

4 days ago

San Mateo A, Philippines Golden East Drive Laboratories, Inc. Full time ₱220,000 - ₱300,000 per year

· This position requires a license at least a graduate of BS Chemistry, BS Microbiology, BS Pharmacy, or any related courses.

· He/she must understand the interactions between the company's various regulatory and GMP requirements.

· responsible for maintaining the Company's Archives. He/she prepares, issues and keeps all manufacturing process documents. , Documenting complaints and recalls is also his/her responsibility. He/she is also responsible for product registrations, license renewals, periodic updates, and registrations to regulatory agencies.

Duties and Responsibilities:

  • Prompt issuance of manufacturing records and forms to insures smooth flow of production schedules.
  • Advise departments on the document management process.
  • Verify that documents conform to the company standards prior to release.
  • Receive and process documents from all departments.
  • Register, index, and classify documents in the document management system.
  • Record, publish, and notify as to the availability and update of all documentation.
  • Participate in establishing procedures, guidelines, and forms.
  • Collect and coordinate information and prepare regulatory documentations for submission to regulatory agencies or to commercial partners.
  • Advise on the regulatory agency submission strategy.
  • Timely compile materials for license renewals, updates and registrations.
  • Maintain regulatory files/database and chronologies in good order.
  • Establish and maintain a system for tracking changes in documents submitted to agencies or partners.
  • Review (proof) labeling and label for compliance with regulatory requirements.
  • Maintain knowledge of FDA, BAI, PDEA, and other relevant international regulations, guidance, and standards applicable to the company's products.

Job Type: Full-time

Pay: Php22, Php25,000.00 per month

Benefits:

  • Additional leave
  • Company events
  • Employee discount
  • Health insurance
  • Life insurance

Work Location: In person

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