Regulatory Affairs Pharmacist <Code: RA>

Gruppo Medica, Inc. We are the makers of innovative products (such as Cherifer), and a fastgrowing manufacturing company engaged in the manufacture of health
products. We are looking for dynamic and progressive minded individuals to
join our group.

Responsibilities

• Handle and manage product registrations, amendments, and variations with the Food and Drug Administration
• Monitor and prepare documents to ensure that the License To Operate of the establishment and the product registrations/notifications are valid
• Ensure that all printed packaging materials and promotional materials are aligned and updated to the latest regulatory requirements
• For Cosmetics: Prepare Product Information File (PIF) for all cosmetic products and ensure that they are updated
• For Cosmetics: Handle DENR-related submissions and registrations of imported raw materials for cosmetics use
• Assist in Pharmacovigilance activities and EDPMS submission
• Assist in FDA audits; prepare necessary documents and Corrective and Preventive Action Plan (CAPA) as necessary
• Assist in the preparation and updating of the Risk Management Plan (RMP)
• Ensure compliance of the establishment with the latest regulatory requirement/s

Requirement

• Preferably a registered Pharmacist
• Experience in this field is an advantage, but not necessary
• Good communication skills and can work well within a team
• Must be hardworking, flexible, responsible, reliable, competent and can work with minimum supervision; organization skills are an advantage
• Must be knowledgeable in using Microsoft Office (Windows, Excel, PowerPoint), and preferably also graphic-related software

Must be willing to work in Calamba City, Laguna or Alabang, Muntinlupa City