Regulatory Affairs Pharmacist  

We are looking for a person with in-depth knowledge of ASEAN Regulatory requirements in the registration of pharmaceuticals, medical devices, food supplements marketing authorization and licenses. Knowledge in implementation of pharmaco-vigilance will be an advantage. Quality experience in interacting with Center for Drug Regulation and Research (CDRR), Center for Food Regulation and Research (CFRR) etc

• You will be in-charge of all regulatory issues and affairs related to the company and different regulatory bodies with respect to the products assigned under your responsibility.
• Communicate and coordinate with all manufacturing partners/suppliers with based on local FDA guidelines on product registrations or other pertinent issues as applicable.
• Coordinate and communicate with the concerned quality control and/or regulatory officers of manufacturing partners/suppliers to ensure adherence to mutually acceptable quality standards for the product as required to be complied by FDA Philippines
• Knowledge and skill in review of Product's Technical Dossiers (CTD) and other pertinent documents and issues related to product registration with FDA Philippines.
• Proficiency in research and analysis for information and issues related to product specific knowledge if necessary is expected.
• Create and maintain proactively an updated database of all product registrations and licenses as necessary for renewals and submit the necessary requirements ahead of time.
• Act as the authorized pharmacovigilance officer for the company by actively coordinating the issues of product complaints/quality with the end-user and or regulatory authorities, maintain updated log for submitted product complaints etc.
• Represent the company in various FDA sponsored activities, public hearings and seminars as necessary.

• Licensed Pharmacist
• 2 years experience as regulatory pharmacist
• Must have experience in handling medical devices and drugs