Regulatory Pharmacist

Salary:
Location: Makati & Batangas

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

? 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.