Özgül Güngör Çulcu
Freelance Global Regulatory Affairs & Quality & Clinical Consultant
Istanbul,34
Summary
Freelance RA/QA/Clinical Expert Consultant_ EU MDR & ISO 13485 & MDSAP Expert_ Remote & Interim Roles_Regulatory Affairs_ Open to Global Opportunities for Medical device compliance and Medicinal/ Pharmaceutical product life cycle management
Overview
21
21
years of professional experience
7
7
Certifications
3
3
Languages
Work History
QRM Consultant
Self-Employee
05.2025 - Current
- Freelance RA/QA/Clinical Expert Consultant_ EU MDR & ISO 13485 & MDSAP Expert_ Remote & Interim Roles_ Medtech Regulatory Affairs_ Open to Global Opportunities for Medical device compliance
Global Regulatory Affairs & Quality & Medical Director
Evmann Investments Holding BV
11.2023 - 04.2025
- Regulatory Affairs and Quality and Medical department Management and MDR Compliance of all Companies that are members of Evmann Investment Holding
Director of Regulatory Affairs and Quality
VSY Biotechnology
02.2021 - 11.2023
- Management& Coordination of RA and Quality Departments
- Member of Evmann Investment Holding
Group Manager of Technical Operations
VSY Biotechnology
07.2020 - 02.2021
- Management of R&D and Quality and Medical (Clinic & RA) Departments
- An Affiliate Member of Evmann Holding
R&D Executive
Santa Farma Pharmaceuticals
06.2018 - 04.2020
- Pharmaceutical Development of new products, improvement, alternative source and Export projects and managing Formulation team and reporting to R&D Director and pre-preparation of CTD for all projects.
Global Head of Regulatory Affairs
Occlutech
11.2017 - 04.2018
- C-level management on all Occlutech RA activities; Managing and coordinating FDA& Health Canada& ANVISA & CE markings and international registrations of Occlutech products in accordance with applicable standards & regulations in order to necessary permits, in accordance with R&D, develop and execute pre-clinical testing as may be required to support FDA approvals, CE marking or international registrations of Occlutech products, perform revisions of Regulatory Affairs- related process or product -related documentations, maintain up-to-date documents, manage and update risk analyses of Occlutech product in cooperation with the related departments responsible and follow the process of revision performed, manage and lead the communication with notified bodies and competent authorities regarding any changes applied to Occlutech products and obtain necessary approvals in a timely manner, identify and address any the shortcomings RA related matters identified by notified body or other relevant agencies, provide the necessary approvals and permits from the relevant consulates for the products and/or company for international registrations.
Regulatory Affairs Manager
VSY Biotechnology
02.2014 - 11.2017
- - Serves as an effective business partner who works with cross functional business team members to support the new product commercialization cycle through documentation development, review and compilation of appropriate technical information for supporting regulatory submissions, CE documentation - Manages interactions with regulatory agency personnel in identified regions, in order to expedite approval of applications, and responses to questions. - Manage the market access needs - Serves as an effective business partner who works with cross functional business team members to support the new product commercialization cycle through documentation development - Conducts OEM/OBL process - Conducts the technical correspondences and business relationship with the companies of contract manufacturing - Manages interactions with regulatory agency personnel in identified regions, in order to expedite approval of applications, and responses to questions. - Develops training and provides regulatory guidance, and act as subject matter expert to project teams regarding specific product submission requirements. - Conducts renewal process for current registration in countries, - Consults with internal and external resources during the investigation of regulatory requirements for global product development projects, corporate development initiatives and corporate strategic initiatives. - Provides direction, oversight and ensures quality for Regulatory Affairs projects, assuring that project and business objectives are met in a timely and cost efficient manner. - Reviews product labeling and promotional materials to assure compliance with regulatory requirements and consistency with product indication’s and classification. - Manages, directs and coaches the Regulatory Operations team. - Ensures the high quality and timely delivery of registrations, documentation and reporting that is required from the Regulatory Operations team.
International Markets Regulatory Affairs Specialist
Deva
11.2012 - 02.2014
- - International Markets for application files for authorization to operate in the countries concerned shown in the presentation of the Ministry of Health -to supply the requested information and documents by contacting the relevant departments of deficiencies -International Markets (US, EU and conventional-regular markets) in the countries concerned of activity required to do correspondence with the Ministry of Health and other government authorities, monitoring, and record keeping -Variation application and the realization of license renewal and file updates -Regulatory Affairs in the preparation of the documents required for the operation, regulation, filing, archiving, in maintaining all relevant records keeping, following and reporting the actual task to be necessary -Coordinate efforts associated with the preparation of regulatory documents or submissions -Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance -Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures -Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents -Recommend changes to company procedures in response to changes in regulations or standards -Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards -Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies -Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways compliance test requirements, or clarification and follow-up of submissions under review -Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
R&D Formulation Specialist
Bilim İlaç
12.2008 - 10.2012
- Scanning Patent and literature -planning new product trials -planning scale-up production and pilot production -preparing production documents in SAP, -planning and follow stability working -preparing modul III part of regulatory submission dossier -making MOH correspondences about product technical details -making formulation and process enhancement working -attending first industrial production batch -preparing TUBITAK and SAN-TEZ project
R&D Responsible
Merkez Laboratuarı İlaç San. ve Tic. A.S
08.2006 - 11.2008
- Planning formulation and method development working for liquid and semi-solid products making method and process validation planning stability working preparing regulatory submission dossier preparing CE technical file and master file making MOH correspondences making MOH records of new products preparing SOP and quality documents of R&D, following and documentation of TEYDEB and SAN-TEZ projects, being quality inner auditer
Regulatory Affairs Specialist
Alvimedica
05.2004 - 07.2006
- Preparing CE technical file for Registration of Medical Devices, making MOH and Notified Body correspondences, following and documentation of TEYDEB and SAN-TEZ projects, being quality inner auditer
Education
Master's degree - Health Economics and Pharmacoeconomy
Hacettepe University
01.2025
Ph.D. - Biochemistry
Yildiz Technical University
04.2001 -
Master of Science - Clinical Biochemistry
Trakya University
Edirne, Turkey 04.2001 -
Bachelor of Science - Chemistry
Trakya University
Edirne, Turkey 04.2001 -
Skills
Design & Development
Technical Registration
GMP
Pharmaceutical Development
Formulation Development
MDSAP expertise
Product Lifecycle Management
Health economics
Market access
Clinical evaluation
Quality improvement
Clinical writing
Clinical research
Strategic planning
Policy and procedure development
Workflow planning
Strategic consulting
Managing files and records
Teamwork and collaboration
Multitasking
Critical thinking
Team collaboration
Training and mentoring
Quality assurance
Quality control
Project management
Risk management
MDR Compliance
Technical File preparation
Certification
CQI and IRCA certified Medical Devices- ISO 13485:2016 QMS Lead Auditor Course
Publications
- Determination of Impurity Profile through Shelf Life for Rupatadine 1 mg/ml Pediatric Oral Solution by using Reaction Kinetics
- Development of Modified Release Tizanidine HCl Pellets by using Quality by Design
- Formulation Development, in Vitro Evaluation and Stability Study of Aceclofenac Tablet
- Development of Solid Dosage Formulation that has Non-Steroidal Anti-inflamatory effect and evaluation of quality parameters
İletişim Bilgileri
- ogungor08@gmail.com
- Www.linkedin.com/in/özgül-güngör-çulcu-ph-d-06440b49 (LinkedIn)
Timeline
ISO 14971 TRAINING ON APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
06-2025
ISO 10993-1 BIOLOGICAL EVALUATION OF MEDICAL DEVICES TRAINING
06-2025
QRM Consultant
Self-Employee
05.2025 - Current
CQI and IRCA certified Medical Devices- ISO 13485:2016 QMS Lead Auditor Course
02-2025
Global Regulatory Affairs & Quality & Medical Director
Evmann Investments Holding BV
11.2023 - 04.2025
ISO 9001:2015 QMS Internal Auditor
08-2022
Organizational effectiveness and strategic planning
02-2022
Director of Regulatory Affairs and Quality
VSY Biotechnology
02.2021 - 11.2023
Group Manager of Technical Operations
VSY Biotechnology
07.2020 - 02.2021
Project Management
01-2020
R&D Executive
Santa Farma Pharmaceuticals
06.2018 - 04.2020
Industrial property rights and Patents at 3 Moduls
01-2018
Global Head of Regulatory Affairs
Occlutech
11.2017 - 04.2018
Regulatory Affairs Manager
VSY Biotechnology
02.2014 - 11.2017
International Markets Regulatory Affairs Specialist
Deva
11.2012 - 02.2014
R&D Formulation Specialist
Bilim İlaç
12.2008 - 10.2012
R&D Responsible
Merkez Laboratuarı İlaç San. ve Tic. A.S
08.2006 - 11.2008
Regulatory Affairs Specialist
Alvimedica
05.2004 - 07.2006
Ph.D. - Biochemistry
Yildiz Technical University
04.2001 -
Master of Science - Clinical Biochemistry
Trakya University
04.2001 -
Bachelor of Science - Chemistry
Trakya University
04.2001 -
Master's degree - Health Economics and Pharmacoeconomy
Hacettepe University