Regulatory Affairs Associate

3 days ago


Metro Manila, Philippines Ajanta Pharma Philippines Inc Full time

Job Title : Regulatory Affairs Associate

Reports to: Regulatory Affairs Manager

Ajanta Pharma Philippines,Inc.

Regulatory Affairs Associate 

Job Description

 

Responsibilities

Prepare submission of new product licenses and license renewals with the overview of the Regulatory Affairs ManagerPrepare submissions of license variations and renewals based on expiration of CPRs and compliance to strict deadlinesMonitor and set timelines for drug license variations and renewal approvalsWrite clear, accessible product labels, patient information leaflets and product insertsMonitoring of commercial batches align with FDA labeling requirementsEnsure that a company's products comply with the regulations of Philippines Law including the FDA Philippines regulationsCollate, evaluate and check scientific data from a range of sources including post marketing surveillance (phase 4)Prepare and check regulatory documentations as needed in public tender and other sales and marketing-related concernsTake part in the development of marketing concepts and approve packaging and advertising before a product's release in conjunction with product managementMaintain proper archive of regulatory documents for reference and easy retrievalPerform other duties that may be assigned by superiors

 

Qualifications and Skills

Graduate of Pharmacy or Industrial PharmacyUpdated Valid PRC Pharmacy LicenseWith at least 1-to-2-year experience in regulatory affairs with Phil. FDA particularly handles drug productsUnderstanding of both legal and scientific matters pertaining to pharmaceuticalsThe ability to grasp new concepts quickly and to assimilate and evaluate scientific data from scientific literatureAnalytical and problem-solving skillsWritten and oral communication skillsAttention to detailThe ability to work under pressure and to strict deadlinesThe confidence to report to higher managementTeam working skills Project-management skillsIntegrity and a professional approach to work

                                     



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