R&D-Pharmacist

Responsible for ensuring the company and its products comply with Philippine FDA regulations, government requirements, and applicable industry standards. The role handles product registration and accreditation, prepares and submits regulatory documents, monitors FDA submissions and correspondence, and ensures compliance with Good Manufacturing Practices (GMP). The position also coordinates with internal departments and regulatory agencies, monitors product promotional materials for compliance, researches regulatory requirements, and ensures timely completion of all regulatory activities and requirements.

• Responsible for ensuring compliance with applicable government rules and regulation.
• Determine and communicate drug approval requirements.
• Compile and submit documents to regulatory agencies.
• Participate as a member of a regulatory team.
• May review drug promotional and advertising material to ensure that it is compliant with regulations.
• Respond to regulatory officials and meet deadlines.
• Research the policies of each country where the company aims to distribute company products.
• In charge of registration and accreditation of new products.
• Collaborating with Purchasing Department, Production/Warehouse Plant.
• Responsible for managing all matters concerning the FDA regulatory requirements.
• To attend accredited training and learning seminars.
• To ensure the company and all products distributed follow FDA regulations.
• To monitor and ensure good manufacturing practices procedures are implemented.
• Responsible for managing all matters concerning the FDA regulatory requirements.
• Knowledge and experience with Philippines FDA procedures, regulations and procedure.
• Monitor submissions of Product registration and other related regulatory correspondences with FDA.