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 BatangasJOB DESCRIPTION? Responsible for ensuring the compliance of the documents per FDA Guidelines for theInitial Applications for Medical Device & Drug Applications upon submission to theFDA to merit approval and secure a Certificate of Product Registration.? Ensures that approval and Certificate of Product Registration will be given for the InitialRegistration 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 FDAfor 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 andLTO Renewal.? Responds to clients queries when it comes to applications and other correspondingconcerns.? Evaluates legal documents as per FDA requirements, makes sure that all LegalAgreements are valid upon submission to FDA.? Keeps up-to-date with changes in regulatory legislation and guidelines and disseminatesthe updates to Regulatory Team.? Ensures that quality standards are met and submissions meet strict deadlines for theapplications.Office address:Brgy. San Isidro Makati CitySalary: 20,000 – 30,000