Regulatory Pharmacist

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.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 be assigned in Makati and Batangas