Regulatory Affairs Pharmacist

4 days ago

Caloocan City Central Post Office, Philippines Lifestrong Marketing Full time
  • Prepares and check submission of License to Operate renewal and other inter-related regulatory correspondence with FDA.

OPERATIONS

  • Ensures that formulation conforms to FDA standards and is within the approved limit.
  • Ensures that labels of new and existing items conform to FDA Standards.
  • Checking of e-Portal for newly approved CPN/CPR's. Download, file and update the Notifications Summary.
  • Generates barcode and monitoring of registration on-line.
  • Ensures that Vidamed warehouses are complying with FDA requirements.
  • Assists FDA inspector with the needs during inspection and makes sure that company is compliant.
  • Conducts product tests for all finished goods distributed and imported by the company.
  • Maintain current knowledge of relevant regulations in Cosmetic/Food/Medical device/Drugs and keeping up to date with changes in regulatory legislation and guidelines.
  • Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
  • Coordinates the schedule of pest control.

SUPPLIERS

  • Monitoring in conducting annual audits of all active suppliers.
  • Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
  • Conducts a Product Information File for filing based on ASEAN Cosmetic Directive.
  • Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.

OTHERS

  • Perform other related duties as required by FDA and other tasks assigned as needed.
  • Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.
  • Reviews Standard Operating Procedure based on the actual activity.
  • Ensures that all pertinent documents for Cosmetic, Food, Drug and Medical Device are available for FDA inspection.
  • Compiles and maintain complete technical data of each product by timely update of LTO's master file.
  • Ensures reliable IPO/Trademark monitoring
  • Assists in addressing all customer inquiries by providing retention and product test results within 2 working days upon request.
  • To ensure that product samples of new batches are distributed for testing 7 working days upon receipt.
  • To provide product testing to Purchasing Dept. 20 working days after product test distribution or before product release to the market (for urgent testing).

Job Type: Full-time

Benefits:

  • Company Christmas gift
  • Company events
  • Employee discount
  • Opportunities for promotion
  • Paid training
  • Promotion to permanent employee

Education:

  • Bachelor's (Preferred)

Experience:

  • Regulatory Pharmacist: 1 year (Preferred)

Language:

  • English (Preferred)

Work Location: In person

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