Regulatory Pharmacist

QUALIFICATIONS
-Licensed Pharmacist and familiar with FDA and PDEA ruling
-With more than 2 years of work experience in the field of Regulatory
-Possesses good interpersonal and communication skills
-Attentive to details, analytical, and result-oriented
-Excellent oral and written communication skills
-Hard-working, result-oriented and strong drive to succeed
-Willing to do fieldwork/ leg work
-Willing to assign in Makati and Batangas

JOB DESCRIPTION
-Responsible for ensuring the compliance of the documents per FDA Guidelines for the
Initial Applications for Medical Device & Drug Applications upon submission to the
FDA to merit approval and secure a Certificate of Product Registration.
-Ensures that approval and Certificate of Product Registration will be given for the Initial
Registration of Medical Device Initials, and Notifications.
-Responsible for renewal and revalidation of LTO & Certificate of Product Registration
-Communicates with the suppliers, evaluates and prepares the requirements for CMDN/
CMDR submission.
-Responsible for variation/amendment applications of Certificate of Product Registration.
-Responsible in having follow-ups for the applications that were not yet evaluated by FDA
for timely release of approval from FDA.
-Able to submit compliance on or before the deadline as prescribed by FDA.
-Prepares documents for regulatory purposes/FDA concerns such as LTO application and
LTO Renewal.
-Responds to clients queries when it comes to applications and other corresponding
concerns.
-Evaluates legal documents as per FDA requirements, makes sure that all Legal
Agreements are valid upon submission to FDA.
-Keeps up-to-date with changes in regulatory legislation and guidelines and disseminates
the updates to Regulatory Team.
-Ensures that quality standards are met and submissions meet strict deadlines for the
applications.

Salary: 20,000 – 30,000