Elçin Döngel
Regulatory And Medical Affairs Intern
Istanbul
Summary
I am a detail-oriented Regulatory Affairs Intern with experience in the pharmaceutical industry. My background in Bioengineering, alongside internships at Kenvue and Sandoz Pharmaceutical, has provided me with a solid foundation in regulatory compliance and quality control. I am committed to ensuring products meet health standards while thriving in dynamic environments that enhance operational efficiencies.
Overview
2
2
years of professional experience
1
1
Language
Work History
Regulatory and Medical Affairs Intern
Kenvue (Johnson & Johnson Consumer Health)
11.2024 - Current
- Monitored Health Authority platforms (TİTCK, SGK, ÜTS) and official government pages daily to track and evaluate regulatory updates, announcements, and guideline changes; maintained records in “Monthly Risk Assessment Kılavuzlar” file.
- Conducted weekly analysis of the Detaylı İlaç Fiyat Listesi and cosmetic product notification statuses on the ÜTS portal, updating the team and documenting progress in the “ÜTS Product Status” tracker.
- Collaborated with the Regulatory Affairs Specialist in regularly reviewing Health Authority Letters; recorded and archived them in “e-başvuru/gelen yazı” and “Kurumdan Gelen Yazılar” files, and linked relevant letters to respective product dossiers.
- Organized and participated in monthly Regulatory Intelligence Assessment Meetings, preparing necessary documentation, obtaining approvals for Risk Assessment Forms, and archiving materials via Regulation Tracker systems.
- Managed cosmetic product notification process, including the collection of required information, artworks, and visuals; maintained the “RA QA Common Product List” and updated relevant systems (RegPoint, CEDMS) following submission.
- Supported internal documentation, archiving, and cabinet indexing procedures; ensured version control and regulatory compliance of all files.
- Uploaded Health Authority Letters, submission dossiers, and notification files to CEDMS weekly, maintaining alignment with internal SOPs.
- Conducted monthly reviews of the Advertising Board website; summarized and reported newly published decisions or guidelines relevant to product promotion.
- Prepared and submitted regulatory file applications and supporting documentation.
- Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
- Assisted in the preparation of regulatory submissions for timely approvals.
Quality Control Laboratory Intern
Sandoz
Istanbul, Istanbul
07.2023 - 08.2023
- Gained hands-on experience in a high-standard pharmaceutical environment, ensuring compliance with quality and safety regulations.
- Performed analytical tests on raw materials, in-process samples, and finished products to verify compliance with industry standards.
- Developed technical skills with various laboratory instruments, including spectrophotometers, centrifuges, and pipettes.
- Improved data accuracy through careful sample preparation, analysis, and documentation.
- Operated advanced laboratory equipment, including HPLC, GC, and spectrophotometers, to conduct precise quality control analyses.
- Gained familiarity with Standard Operating Procedures (SOPs) and adhered to strict laboratory protocols to maintain accuracy and reliability.
Education
Bachelor of Science - Bioengineering
Yıldız Technical University
Istanbul, 34 04.2001 -
Erasmus - Chemical Engineering
Wroclaw University of Science And Technology
Poland 04.2001 -
Skills
- Teamwork and collaboration
- Fast and quick learner
- Presentations
- Goal-oriented mindset
- Multitasking and organization
- Attention to detail
- Communication
Timeline
Regulatory and Medical Affairs Intern
Kenvue (Johnson & Johnson Consumer Health)
11.2024 - Current
Quality Control Laboratory Intern
Sandoz
07.2023 - 08.2023
Bachelor of Science - Bioengineering
Yıldız Technical University
04.2001 -
Erasmus - Chemical Engineering
Wroclaw University of Science And Technology
04.2001 -