Porntipa Chairuangkitti

Experience

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  Profascino Co. Ltd.

  Jun 2012 - Jun 2014

  Community Pharmacist

  • Dispensing and counseling for customers.

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  Kaspa pharmaceutical

  Jul 2014 - Dec 2015

  Regulatory Affair Associate

  • Pharmaceutical products: registration and variation for Generic and New generic drugs, BE report, Biowaiver (BCS class 1).• Prepare documents for GMP clearance (PICs and non-PICs).• Provide a strategic regulatory framework for the submission and support of advertisements.• Collect, evaluate, and compile scientific data and information on products.• Write clear, accessible product labels and patient information leaflets.

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  BJC (Public) Co.,Ltd.

  Jan 2016 - Dec 2021

  Registration Manager

  • Pharmaceutical products: registration (ACTD and amendment for new drugs, biological drugs, generic drugs, and new generic drugs) required bioequivalence studies or biowaiver studies.• Develop registration strategies for new pharmaceutical products and medical devices.• Coach the regulatory affairs trainee to understand the RA's responsibility.• Review and comment on the Quality Agreement and required documents for GMP clearance and transfer license.• Medical device: Risk-based classification, CSDT registration file.• Review the accuracy and completeness of promotional materials, provide feedback, and update packaging materials and promotional materials according to regulatory and marketing purposes.• Apply for lot release certificate of biological products and collaborate with the marketing and shipping team to manage the local shipment.• Review compliance among registered, imported COA, and translated COA.• Collaborate with the Pharmacovigilance team and manage safety issues including product recall.• Create and revise SOPs for safety and regulatory concerns. Show less

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  GeneusDNA

  Mar 2022 - Nov 2022

  Project Manager and Pharmacist

  • Review project proposal or plan to determine time frame, estimation, and procedures for accomplishing projects.• Responsible for managing overall directions and integrity of projects through project-level reporting such as preparing presentations and training programs.• Plan direct and coordinate activities of designated projects to ensure that the goals or objectives of projects are accomplished within the limited time frame.• Confer with project staff to outline work plan and to assign duties such as website and application developer team, and online marketing team with analyzing customer's needs and give direction for overall responsible projects.• Identify and solve problems/risks and support sales personnel to come up with effort estimation based on discussions with customers/third parties. Show less

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  PharmEng Technology

  Dec 2022 - Jan 2023

  Regulatory Affairs, Quality Assurance, Pharmacovigilance consultant

  • Regulatory Affairs: Cover end-to-end all aspects of regulatory projects for the marketing strategies and provide solutions to clients in product registration by providing regulatory support and intelligence, review for compliance, translation, submission of dossier to health authority locally or regionally, and following up on post-approval commitments, life cycle management.• Pharmacovigilance: Local qualified person for Pharmacovigilance reporting and support other PV in the region• Quality Assurance: Support Quality Management System of Good Distribution / Storage and Supply Practices in Thailand for Marketing Authorization Holding• Project management: Involved with business development and execution of projects related to regulatory affairs, Pharmacovigilance, and quality assurance with a thorough understanding of regulations and industry practices, open to any scope that may come by in the pharmaceutical consulting service industry.• Supporting Functions: Open to new challenges and new scopes including general management and marketing of the business. Show less

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  Boehringer Ingelheim

  Feb 2023 - Feb 2025

  Senior Regulatory Affairs Executive

  • Regulatory Affairs and Pharmacovigilance: Manage all product life cycles in regulatory affairs and pharmacovigilance aspects. • e-CTD, ACTD, and e-submission of new registration, license renewal, and variation of new drugs, biological drugs, and vaccines.• GMP clearance application and renewal (PIC/s, certified by PIC/s and Non-PIC/s)• Monitor and give regulatory advice on promotional/advertisement/related activities to the business department to comply with FDA regulations/laws including local labeling and packaging and review promotional materials to comply with local regulations and internal policy.• Strategic planning: Provide regulatory support and maximize the business profit.• Collaborate with supply chain, QA, and other cross-function to support business continuity.• Submission for a certificate of batch release for each batch of all vaccines imported.• Pharmacovigilance activities and ensure compliance with national regulations for adverse events reporting or any regulatory safety monitoring activity.• HA advocacy: RAPAT: REGULATORY AFFAIRS PHARMACY ASSOCIATION (THAILAND) committee contributed as a working group about the renewal license announcement with the Thai FDA.• Representative of AAHA (ASIAN Animal Health Association) to provide the guidelines for e-submission of vet-vaccine and biological products.• Coordinate and oversee regulatory activities such as Myanma.• Maintain the regulatory internal system: DAVID, ONEPAC, BIRDS, SLCI (SAP)• Create and update SOPs compliance with global and local SOPs Show less