Licensed (Regulatory) Pharmacist

Company: Pros-Apac Corporation
Malate, Manila
PROS-APAC Corporation is URGENTLY HIRING of a LICENSED REGULATORY PHARMACIST.
The Licensed Pharmacist will lead the regulatory affairs of the company.
• Register and renew all the products that are being sold by the company.
• Gather, evaluate, organize, manage, and collate information in the form of dossiers from a variety of suppliers.
• Answer emails that are in connection with the regulatory affairs of the company.
• Evaluate and manage License To Operate of the company.
• Monitor documents and certificates of accreditations to local government agencies and instrumentalities.
Specific duties and responsibilities:
• To reconciles on a weekly basis the Comprehensive List of Products under registration (the status of the products applied whether on process or finished) with BFAD Regulatory Affairs Pharmacist.
• To notarized application form that is submitted to the Food and Drug Administration for products that will require it.
• To submit to the Food and Drug Administration the Dossiers for Product Registrations and Renewals of Certificate of Product Registrations.
• To coordinate with various supplier regarding the requirements for product registration and submission requirements.
• To inform supplier regarding the status of product registration throughout the products lifecycle.
• To monitor the stickering of product registration number, importer, distributor to every product in the warehouse department.
• To be abreast with the updates and new regulations of the Food and Drug Administration.
• To represent the company during Philippine Association of Medical Device Regulatory Affairs Professional Society during its annual meetings and ad hoc meetings and email queries.
• To manage quality assurance related matters including internal and third-party audits, product release, deviation reports, quality complaints and recalls.
• To perform review of all product packaging materials and ensure that it complies with the existing laws and regulations of the regulatory body.
• To answer sales queries, coordinate, update products for renewals and other related issues concerning medical devices.
• A graduate of BS in Pharmacy.
• With valid PRC Certificate and License
• With QPIRA Certification of Medical Device & Drugs is an advantage
• with 1-2 years experience working experience as company pharmacist
• With good relational skills
• With strong analytical skills, easily assess emergency conditions and implements appropriate intervention
• Ability to multi-task
• Highly proficient in written and verbal communication skills.
Interested applicants, may send or email resume/biodata to Click to view.