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Sales & Regulatory Affairs Executive - Pharmacist

2 months ago

Metro Manila, Philippines Ambica International Corporation Full time
 Job DescriptionThe Sale and Regulatory Affairs communicates with the regulatory department for the needed documents from suppliers, such as PIC/s GMP Certificate, Apostilled WHO-GMP Certificate (if non-PIC/s country), GMP Evidence Dossier, Product Stability Studies Report, Certificate of Pharmaceutical Product (COPP), Certificate of Analysis (COA) of Finished Product and actual product samples for Local Assay TestingCommunicates with Regulatory department for the needed documents from their end, such as Regulatory Status Reports for PCPRs and CLIDPs, CGMP Report, receiving copies/proof of submission for initial/renewal/variation of PCPRs and CLIDPs to FDA, copies of new/renewed PCPRs, CLIDPs, Food CPRs, Medical Device Certifications, Cosmetic Notifications and Certificate of GMP Compliance, copies of approved Certification for Variation and Batch NotificationCommunicates with XDs, Lead Coordinators, Sales Coordinators, and clients/distributors regarding inquiries on FDA process/updates for initial/renewal/amendment application of products, active CPR details/latest status or remarks, ADR Reports, technical product issues, and other Regulatory mattersKeeps updated files of all documents submitted and received from the FDA and other Regulatory-related documents/reports from XDs, Lead Coordinators, Sales Coordinators, and Regulatory departmentProvides the needed documents of XDs, Lead Coordinators, Sales Coordinators and clients/distributors from the Regulatory department, such as receiving copies/proof of submission for initial/renewal/variation of PCPRs and CLIDPs to FDA, copies of new/renewed PCPRs, CLIDPs, Food CPRs, Medical Device Certifications, Cosmetic Notifications and Certificate of GMP Compliance, copies of approved Certification for Variation and Batch NotificationKeeps the updated files of the Regulatory Status Report, CLIDP Status Report, and CGMP List Report from the Regulatory departmentPrepares and updates Ambica Product List by Therapeutic Category from time to timePrepares and updates List of Ambica Products as per requested Therapeutic Category or Field of Medicine and/or as per request of XD or clientChecks the latest status of the submitted applications to the FDA through the FDA DocTrack Status website as per request of XDs, Lead Coordinators, Sales Coordinators, and clients/distributors for CPR and product inquiries/issuesContact FDA trunkline and communicate with FDAC Officers/FDA Evaluators for the latest/current DocTrack Status update for submitted applications, and follow-up submitted applications, or respond to queries if neededChecks and reviews the artwork of products for local printing/box replacement and signs the approved artwork afterwardChecks the artwork/layout for flyers, brochures, leaflets, or other advertising material as per FDA regulation guidelines for Sales Promo Permit Applications in FDAPrepares necessary documents, such as Integrated Application Form, Promo Mechanics Sheet, and Letter of Intent, required for submission for Sales Promo Permit Application in FDASubmits the documents for the Sales Promo Permit Application to the FDASearch and contact local suppliers for purchase of Antibiotic Sensitivity Discs as requested by XDs, Medical Representatives, and clientsResearch and coordinate with the Accredited Laboratories for conducting Assay for drug products as requested by XDs, Medical Representatives, and clientsReceives, responds, and/or complies to notification mail/s from the Monthly Index of Medical Specialties (MIMS) and from the Philippine Pharmaceutical Directory (PPD) for product monographs for quarterly/annual book issueGather references needed for checking, and reviewing entries, such as latest/updated PCPR/CLIDP copies, product inserts, artworks, and Regulatory Status ReportsChecks and reviews product monographs for quarterly/annual book issues of MIMS and PPDRetrieves and provides Regulatory documents like latest/updated CPR copies, approved certifications, and artwork for product monographs with corrections or new updates for MIMS and PPDSubmit the reviewed product entries/monographs to MIMS and PPD through email before the due dateCheck and submit Product Packshots and Images for Product List to MIMS if requestedCoordinates the inquiries regarding products, product monographs, and documents of Ambica products included in the listing of MIMS and PPDAttends to Medical Mission hosted by Ambica International CorporationUphold a strict level of confidentiality.Work proactively within time constraints and perform any other relevant function as may be advised.Job QualificationsBachelor of Science Degree in PharmacyProfessional Certification:He/She should be a PLE Board Passer.He/She must have a registered/valid PRC ID as a PharmacistFamiliar with products under Drugs, Food, Cosmetics, and Medical Devices.Knowledgeable towards Regulatory work, such as Product Registrations in FDA.Good in oral and written communication in English.Computer-literate, especially the use of Microsoft Office Apps and emails.Experience is not required as fresh graduates may apply. But preferably, he/she has experience with Regulatory work, specifically in (1) Product Registrations in FDA and (2) Product Inclusion Requirements, and Processes in Community Pharmacies and Hospitals.