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.
Office address:Brgy. San Isidro Makati City
Salary: 20,000 – 30,000