Zülal İlter Paltaoğlu

Experience

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  Mustafa Nevzat İlaç

  May 2010 - Dec 2011

  Regulatory Affairs Specialist

  - Providing all required documents from related departments to prepare CTD dossier (for variations, renewals and submissions) according to the requirements of the country of submission- Preparing responses to deficiency letters after submissions in a timely manner - Preparing Module 2.4 and 2.5 Sections- Preparing SmPC and PILs

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  Abdi Ibrahim Pharmaceuticals

  Dec 2011 - Oct 2020

  - Supervising the regulatory team. Prioritizing targets and delegating tasks effectively. Performance management in line with company strategies and needs- Deciding strategies and timelines for all types of regulatory submissions for all approved and upcoming medicinal products (Prioritization submissions, new MA submissions, variations, renewals, labels, etc.)- Organising GMP Submissions and renewals with the authority and related manufacturing sites. Accompany the inspectors during the audits - Close follow up for the situations of the submissions in parallel with company strategies. Make effective communications with all internal and external stakeholders- Effective project and time management for all projects in line with estimated launch dates. - Monitoring the regulatory environment and give information to related departments- Following the regulations closely. Give feedbacks to draft guidelines. Get necessary actions accordingly, if needed making announcements to related teams proactively- Thinking proactively and focusing on solving the problems Show less For Turkish Market (06.2015 - 12.2017)- Dossier preparations and submissions in line with company strategies. Closely following up the situation of the dossier at MOH side after submission. Creating effective and fast solutions to accelerate the approval procedure- Planning timeline and submitting for MA renewals- Variation submissions (both for technical and administrative parts of the dossier). Getting in line with all related departments regarding the variations and make them aware for any upcoming changes- GMP Submissions and coordination before and after the audits- Co-Marketing submissions- Preparing&updating labels (inner and outer packaging with SmPC&PIL) in accordance with the guidelines- Food supplement submissions - Having good communication skills both with internal and external colleagues and/or partnersFor International Markets (12.2011 - 06.2015)EU Countries:- Preparations and dossier submissions via National procedure, DCP or MRP on e-CTD - After submissions, closely following up the deficiency letters with the authorities. Make necessary communications to prepare responses for deficiency letters within determined timelines- Preparing and getting technical approvals to the labels- Submissions for all types of variations - Following EMA guidelinesOther Countries: (Kazakhstan, Russia, Kosovo, Tunisia, Azerbaijan, Georgia, Turkmenistan, GCC, Algeria)- Providing all required documents from related departments to prepare CTD dossier (for variations, renewals and submissions) according to the specific country requirements - Replying the questions and deficiencys received from partners and/or authorities. - Preparing and getting technical approvals to the labels- Submissions for all types of variations - Following international pharmaceutical guidelines- Solving the problems occurring within day for any issue about the Regulatory Procedures Show less

  • Regulatory Affairs Supervisor

    Jan 2018 - Oct 2020

  • Regulatory Affairs Specialist

    Dec 2011 - Dec 2017
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  AIFD | Araştırmacı İlaç Firmaları Derneği

  Jun 2021 - now

  Health Policy Manager