Now Hiring: Regulatory Pharmacist
For Multinational Drug Company
c/o Sandoval Distributors, Inc.
AB Sandoval Bldg., Shaw Blvd., Pasig City
4 Years or more in Regulatory Work. Well experienced in applying / securing CPRs, Baby CPRs.
1. Responsible for managing all matters concerning the FDA regulatory requirements specially for Drug Products
2. Knowledge and experience with Philippines FDA procedures, regulations, and procedure
3. Facilitate and monitoring of submissions of LTO, CPRs and other related regulatory correspondences with FDA.
4. Develop, maintain and monitor schedule of periodic updates for all regulatory submissions, follow ups etc.
5. Ensure that all FDA licenses, certificates, and permits are updated and valid
6. Proficiency in creating/reviewing packaging layouts in line with existing standards set by FDA
7. Responsible for having follow-ups for the applications that were not yet evaluated by the FDA for timely release of approval from the FDA.
8. Compile and check the drug dossiers for proper filing with the FDA
9. Work with PDEA in registering and reporting regulated (yellow prescription) products.