The Regulatory Pharmacist is responsible for the review and evaluation of dossiers for identified priority products, ensuring compliance with the Philippine FDA's requirements and submission deadlines. The role involves coordinating with suppliers, preparing artwork, and supporting regulatory officers in FDA submissions and database management.
Key Responsibilities:
Dossier Review and Evaluation:

• Conduct thorough reviews of dossiers for priority products.
• Evaluate the completeness and accuracy of dossier content.
• Take into account the exchange of communications between the Regulatory Officer in-charge and the supplier.
• Identify and address any discrepancies or missing information.

Artwork Preparation:

• Prepare artwork for dossiers as per Philippine FDA requirements.
• Ensure artwork meets all regulatory standards and guidelines.

Supplier Coordination:

• Liaise with suppliers to request additional information or clarifications.
• Facilitate effective communication to resolve any issues related to dossier content.

Initial Registration, Monitored Release Registration, Variation Applications, and Notifications:

• Review and evaluate dossiers provided by suppliers/clients for various regulatory applications.
• Ensure all required documentation is complete and compliant.
• Prepare artwork as needed for these applications.

Support to Operations:

• Assist colleagues in preparing and submitting dossiers to the Philippine FDA.
• Ensure all submissions are accurate, complete, and timely.
• Update the database with relevant information related to dossier submissions and communications.
• Maintain an accurate and up-to-date database of all regulatory activities.

Job Type: Full-time
Pay: Php22,000.00 - Php25,000.00 per month
Benefits:

• Company events
• Employee discount
• Flexible schedule
• Health insurance
• On-site parking
• Opportunities for promotion
• Paid training
• Pay raise

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Supplemental Pay:

• 13th month salary
• Overtime pay
• Performance bonus

Expected Start Date: 01/01/2025