Betül Dalkıran
International Markets Regulatory Affairs Project Leader
Istanbul
Summary
Proficient in current human medicine regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
7
7
years of professional experience
7
7
years of post-secondary education
2
2
Certifications
Work History
Regulatory Affairs Project Leader
Abdi Ibrahim Pharmaceuticals
01.2022 - Current
- Preparing and submitting regulatory file applications and supporting documentation.
Taking necessary actions to maintain product life cycle (submissions of renewals, Type IA- Type IB- Type II variations, post-approval changes). - Implemented regulatory guidance procedures for EU and UK regions.
- Control of artwork designs prepared by labeling department.
Providing support to customers for out-license projects. - Providing support to business development and marketing departments for in-licensing projects.
Reporting monthly project updates by using designated presentations - Successfully leading multiple projects simultaneously while maintaining a focus on priorities, resource allocation, and overall strategic objectives.
- Ensuring compliance with industry regulations by staying informed about changes in legislation affecting the company''s operations or projects.
- Evaluating new business opportunities from a regulatory perspective, providing valuable insight into potential challenges or benefits.
- Establishing strong relationships with global regulatory counterparts, facilitating efficient information exchange and collaboration.
- Coordinating recall or market withdrawal activities as necessary.
- Using ectd software to create common technical dossiers for submissions targeted for EU and UK regions.
Regulatory Affairs Specialist
Santa Farma Pharmaceuticals
12.2020 - 01.2022
- Prepared and submitted regulatory file applications and supporting documentation.
- Prepared and submitted post-approval variations and renewal dossiers.
- Implemented regulatory guidance procedures for local and international markets.
- Prepared and maintained document inventory for core dossier preparation.
- Supported product development by offering guidance on applicable regulations throughout the process, ensuring adherence at every stage.
- Maintained and archived regulatory paperwork.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
Foreign Trade Regulatory Affairs Specialist
Nobel İlaç San. Ve Tic. A.Ş.
12.2017 - 12.2020
- Prepared and submitted regulatory file applications and supporting documentation for drug registration activities in CIS and Balkan countries.
- Prepared and submitted post-approval variations and renewal dossiers.
- Maintained and archived regulatory paperwork.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Wrote or updated standard operating procedures, work instructions or policies.
Education
MBA - Management And Organization
Marmara University
Istanbul, Turkey 09.2014 - 02.2018
Bachelor of Science - Chemical Engineering
Marmara University
Istanbul, Turkey 09.2009 - 09.2013
Skills
Project Management
Documentation And Reporting
Workload prioritization
Leadership skills
Client communications
Stakeholder Management
Problem-solving abilities
Fluency in Business English
Languages
Turkish
Native language
English
Proficient
C2
French
Elementary
A2
Certification
Drug Discovery- UC San Diego School of Medicine
Software
Microsoft Office
Lorenz DocuBridge
Timeline
Regulatory Affairs Project Leader
Abdi Ibrahim Pharmaceuticals
01.2022 - Current
Drug Discovery- UC San Diego School of Medicine
10-2021
Design and Interpretation of Clinical Trials- The Johns Hopkins University
05-2021
Regulatory Affairs Specialist
Santa Farma Pharmaceuticals
12.2020 - 01.2022
Foreign Trade Regulatory Affairs Specialist
Nobel İlaç San. Ve Tic. A.Ş.
12.2017 - 12.2020
MBA - Management And Organization
Marmara University
09.2014 - 02.2018
Bachelor of Science - Chemical Engineering
Marmara University
09.2009 - 09.2013
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