Regulatory Pharmacist

Salary:
Location: Makati & Batangas

QUALIFICATIONS Licensed Pharmacist and familiar with FDA and PDEA rulingWith more than 2 years of work experience in the field of RegulatoryPossesses good interpersonal and communication skillsAttentive to details, analytical, and result-orientedExcellent oral and written communication skillsResponsible 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 RegistrationCommunicates 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.