Fevziye Gizem Tecimen Akçakaya
Bahçelievler/İstanbul,Türkiye
Summary
Experienced regulatory affairs professional with extensive expertise in regulatory submissions, post-marketing surveillance, and regulatory reporting. Proficient in submission dossier compilation, policy interpretation, and regulatory strategy development. Demonstrates a deep understanding of European Union procedures, pharmaceutical legislation, and pharmacovigilance laws. Skilled in GMP regulations, adaptive decision making, risk management, and compliance monitoring plan development. Committed to advancing pharmaceutical industry knowledge through effective policy development and legislative understanding.
Overview
12
12
years of professional experience
10
10
years of post-secondary education
1
1
Certification
Work History
Regulatory Affairs Executive
GLAXOSMITHKLINE İLAÇLARI SANAYİ ve TİCARET A.Ş.
İstanbul, Türkiye
08.2019 - Current
- Develop best regulatory strategies: continuous analysis of risks and opportunities for new assets requires close follow up of the internal and external trends and strategic planning from early development through launch
♦ Planning and execution of post-approval submissions (renewals, technical variations, new indication, label updates) and conduct effective cross-functional interactions to preserve business continuity
♦ Follow up of developments and changes in the local & global regulations and analyzing the potential impact on the registrations
♦ Interaction with Agency members and external stakeholders
♦ Lead GMP related tasks including inspections which require close follow up with internal and external stakeholders
♦ Act as a key regulatory stakeholder at brand task force groups (contains multiple functions) to provide input/advice
♦ Lead strong relationships with internal and external stakeholders
♦ Ensure the organization’s regulatory activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards
♦ Perform regulatory advocacy activities with internal and external stakeholders
Regulatory Affairs Specialist
World Medicine İlaç San. Tic. A.Ş.
İstanbul, Türkiye
04.2021 - 07.2022
- Maintained an up-to-date knowledge of EU Regulatory Affairs landscape through continuous professional development courses.
- Reviewed promotional materials, ensuing adherence to regulatory guidelines.
- Developed regulatory strategies to facilitate successful product registrations.re
- Established effective communication with regulatory bodies, ensuring transparency in operations.
- Managed and submitted pharmaceutical licensing applications for product approval.
- Contributed to product development planning through insightful risk assessments and mitigation plans.
- Collaborated closely with scientific teams, enhancing understanding of complex technical issues.
- Prepared detailed responses for queries from regulatory agencies, facilitating prompt resolutions.
- Monitored regulatory changes and implemented process and procedure adaptations to suit.
- Edited technical documentation to support country-specific submissions for improved approval rates.
- Collaborated with multi-disciplinary staff to instill culture-wide culture of accountability and compliance.
Medical Regulatory Affairs Specialist
Deva Holding A.Ş.
İstanbul, Türkiye
08.2017 - 04.2021
- Preparation of 2.4 and 2.5 modules from the license application documents within the scope of the Regulatory Submission
- Creation of SmPC-PIL documents for new products and updating of SmPC-PIL documents of old products, submissions and follow-up of license renewal,
- Writing the medical brief summary parts of the reimbursement application files for the pricing unit,
- Organizing the preparation of PIL artworks
- Controlling the strings, providing communication between Deva and the 3rd party of pharmacovigilance for Deva.
- Coordinated audit processes, ensured regulatory compliance.
- Maintained up-to-date knowledge on pharmacovigilance regulations to improve performance in the role.
- Trained staff members on good pharmacovigilance practice, enhancing their skills and competency level.
- Approved safety, regulatory and certification related across various design processes.
Long Term Intership
Abdi İbrahim İlaç
İstnabul, Türkiye
01.2015 - 06.2015
- Performing bench chemistry and instrumental analyzes of raw material samples, interpreting and reporting the suitability of analysis samples in the Raw Material and Finished Product Analysis Laboratory
- Instrumental in setting up and managing internal compliance programmes; ensured strict adherence at all times.
- Collaborated closely with teammates for achieving daily production targets without compromising on quality standards.
- Improved predictive models by utilising advanced data analysis techniques.
Intership
Mustafa Nevzat İlaç A.Ş
İstanbul, Türkiye
07.2013 - 08.2013
- Spearheaded the development of new analytical tools which advanced lab capabilities significantly.
- Trained junior staff in effective use of analytical tools, promoting skill development across the team.
- Complied with construction standards for quality assurance during projects.
Education
Bachelor of Science - Chemistry
Marmara University
İstnabul/Türkiye 09.2009 - 06.2014
Master of Science - Analytical Chemistry (Institute of Health Science)
Marmara University
İstanbul/Türkiye 06.2014 - 08.2019
Skills
- Regulatory submissions
- Post-Marketing surveillance
- Regulatory reporting
- Submission dossier compilation
- Policy interpretation
- Regulatory strategy development
- Legislative understanding
- European union procedures knowledge
- Pharmaceutical legislation expertise
- Pharmacovigilance laws awareness
- GMP regulations understanding
- Adaptive decision making
- Pharmaceutical industry knowledge
- Risk Management
- Compliance monitoring plan development
- Policy development
Languages
English
Upper intermediate
Turkish
Native
Affiliations
- Yoga, Latin Dance
Certification
International Meeting on Education&Research in Health Sciences (IMER-HS) (0.11-05.11.2017) (Poster presentation)
Method Development and Validation for Simultaneous Analysis of Methylprednisolone Aceponate and Benzyl Alcohol in Crema Formulation by HPLC.
10TH AEGEAN ANALYTICAL CHEMISTRY DAYS INTERNATIONAL CONFERENCE (29.09-02.10.2016) (Poster presentation)
Comparison of Three Analytical Columns for the Simultaneous Analysis of Methylprednisolone Aceonate And Benzyl Alcohol
Timeline
Regulatory Affairs Specialist
World Medicine İlaç San. Tic. A.Ş.
04.2021 - 07.2022
Regulatory Affairs Executive
GLAXOSMITHKLINE İLAÇLARI SANAYİ ve TİCARET A.Ş.
08.2019 - Current
Medical Regulatory Affairs Specialist
Deva Holding A.Ş.
08.2017 - 04.2021
Long Term Intership
Abdi İbrahim İlaç
01.2015 - 06.2015
Master of Science - Analytical Chemistry (Institute of Health Science)
Marmara University
06.2014 - 08.2019
Intership
Mustafa Nevzat İlaç A.Ş
07.2013 - 08.2013
Bachelor of Science - Chemistry
Marmara University
09.2009 - 06.2014
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