Aslı Öcal
İstanbul,Türkiye
Summary
A seasoned professional with expertise in Regulatory Strategy & Intelligence, CTD / eCTD Dossier Preparation, and MAA (Marketing Authorization Application). Demonstrates proficiency in Lifecycle Management (Variations & Renewals), SmPC & PIL Development and Artwork Management. Known for exceptional attention to detail, effective interdepartmental coordination, and strong project management skills. Adept at communication and committed to advancing regulatory processes within the pharmaceutical industry.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
Work history
Senior Regulatory Affairs Specialist
Bilim İlaç San. ve Tic. A.Ş.
Istanbul, Türkiye
2023.07 - Current
- Prepared and submitted Marketing Authorization Applications in compliance with CTD/eCTD formats
- Managed the end-to-end registration process for new pharmaceutical products, ensuring timely market access
- Coordinated with cross-functional teams to compile technical documentation for Modules 1-5 of the CTD dossier.
- Providing responses to authorty questions
- Managed the renewal of marketing authorization, MA transfer, co-marketing applications
- Executed variation applications to maintain product licenses
- Monitored and implemented labeling updates for the product portfolio.
- Prepared and updated Summary of Product Characteristics and Patient Information Leaflets.
- Supported team by demonstrating respect and willingness to help.
Regulatory affairs specialist
World Medicine İlaç San. ve Tic. A.Ş.
Istanbul, Türkiye
2022.04 - 2023.07
- Prepared and submitted Marketing Authorization Applications (MAA) in compliance with CTD format.
- Managed the end-to-end registration process for new pharmaceutical products, ensuring timely market access.
- Coordinated with cross-functional teams to compile technical documentation for Modules 1-5 of the CTD dossier.
- Executed variation applications to maintain product licenses.
- Translated and adapted DMF documentation to meet local regulatory requirements
- Prepared and updated Summary of Product Characteristics and Patient Information Leaflets.
- Managed the preparation and submission of renewal dossiers to ensure continuous market availability.
- Managed the preparation and approval of artwork for primary and secondary packaging materials.
- Managed the preparation and approval of artwork for primary and secondary packaging materials.
Regulatory affairs assistant specialist
Tobio Novelfarma
Istanbul, Türkiye
2021.03 - 2022.03
- Executed variation applications to maintain product licenses.
- Managed the preparation and submission of Sales Authorization applications to ensure timely market launch.
- Prepared and updated Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL).
- Managed the preparation and approval of artwork for primary and secondary packaging materials.
Medical regulatory assistant specialist
Deva Holding A.Ş.
Istanbul, Türkiye
2018.12 - 2021.03
- Prepared and updated Summary of Product Characteristics and Patient Information Leaflets.
- Preparation of 2.4 and 2.5 modules from the license
application documents - Writing the medical brief summary parts of the
reimbursement application files for the pricing unit - Managed the preparation and proofreading of artwork for Patient Information Leaflets to ensure regulatory compliance
Internship
Mustafa Nevzat İlaç Sanayii A.Ş.
Istanbul, Türkiye
2016.08 - 2016.09
- Observed pharmaceutical manufacturing processes (granulation, tablet compression, coating, and packaging) in compliance with GMP standards.
- Reviewed Standard Operating Procedures and assisted in the maintenance of batch manufacturing records.
- Followed equipment cleaning validation and line clearance procedures to prevent cross-contamination.
- Followed equipment cleaning validation and line clearance procedures to prevent cross-contamination.
- Followed GLP principles and Data Integrity requirements within the quality management system.
Internship
Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Ti
Istanbul, Türkiye
2015.07 - 2015.08
- Assisted in physical and chemical analysis (titration, pH measurement, melting point, etc.) to verify raw material compliance with specifications.
- Gained hands-on experience in sample preparation and observed the operation of analytical instruments such as HPLC, GC, and UV-Vis spectrophotometers.
- Followed analytical procedures in accordance with current pharmacopeias (USP, EP, and BP).
- Observed raw material sampling procedures and ensured samples were stored under appropriate conditions.
Education
Master of Business Administration -
Yıldız Teknik Üniversitesi
Istanbul 2021.09 - 2022.06
Bachelor of Science - Chemical engineering
İstanbul Üniversitesi
Istanbul 2012.09 - 2018.02
Skills
- Regulatory Strategy & Intelligence
- CTD / eCTD Dossier Preparation
- MAA (Marketing Authorization Application)
- Lifecycle Management (Variations & Renewals)
- SmPC & PIL Development (KÜB/KT)
- Artwork Management
- Attention to Detail
- Interdepartmental Coordination
- Project Management
- Communication skills
- Problem-solving
Languages
English
Intermediate
Turkish
Proficient (C2)
Affiliations
- Pilates
- Hiking
- Watching a limited series
References
References available upon request.
Timeline
Senior Regulatory Affairs Specialist
Bilim İlaç San. ve Tic. A.Ş.
2023.07 - Current
Regulatory affairs specialist
World Medicine İlaç San. ve Tic. A.Ş.
2022.04 - 2023.07
Master of Business Administration -
Yıldız Teknik Üniversitesi
2021.09 - 2022.06
Regulatory affairs assistant specialist
Tobio Novelfarma
2021.03 - 2022.03
Medical regulatory assistant specialist
Deva Holding A.Ş.
2018.12 - 2021.03
Internship
Mustafa Nevzat İlaç Sanayii A.Ş.
2016.08 - 2016.09
Internship
Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Ti
2015.07 - 2015.08
Bachelor of Science - Chemical engineering
İstanbul Üniversitesi
2012.09 - 2018.02