Olga Banaszek
Warsaw,14
Summary
I am a highly motivated and results-oriented Associate Regulatory Manager with over 14 years of experience in the Pharmaceutical Industry. I possess a proven track record in developing and executing complex regulatory strategies for medicinal products from early development through post-market surveillance. I’m expert in preparing, compiling, and submitting major regulatory applications (e.g. renewals, post-approval variations) to the EU Health Authorities, at interpreting and applying diverse regulations, leading cross-functional teams, and ensuring corporate compliance to achieve timely product approvals and maintain market access. I am seeking to leverage expertise to drive strategic regulatory success.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Associate Regulatory Manager
Farmak International. Sp. Z.o.o.
01.2025 - Current
- Supervising and managing the external Pharmacovigilance service provider, including monitoring the activities performed in accordance with the contract, timelines, and quality of services provided;
- Ensuring that the activities of the external Pharmacovigilance service company comply with applicable pharmaceutical law and the internal company procedures;
- Coordinating cooperation between Farmak International Sp. z o.o. and its local branches in the Czech Republic, Slovakia and Spain, and the external Pharmacovigilance service provider, including solving current issues and optimizing ongoing processes;
- Coordinating Pharmacovigilance-related activities in EU countries where the opening of further company branches is planned (France, Italy);
- Co-creating registration strategies for selected medicinal products (sterile and non-sterile products);
- Submitting renewals for medicinal products registered in European/National procedures (MRP/DCP);
- Co-creating the Regulatory Affairs Department budget.
Senior Regulatory Affairs Specialist
Symphar Sp. Z.o.o.
01.2015 - 12.2024
- Verifying Dossier for new potential medicinal products M1-M5 (on-line audits). Recommending the best documentation. Preparing summary reports for clients and for internal team with list of documents to be updated;
- Verifying the regulatory part of License & Technical Agreements with company partners. Providing information concerning regulatory strategy/registration costs;
- Coordinating the registration process of medicinal products with contract manufactures;
- Submitting new registration and application for variation for medicinal products registered in European procedures (MRP/DCP) and national procedure;
- Submitting renewals for medicinal products registered in European/National procedures (MRP/DCP);
- Translating SPCs, Leaflets and Labelling from English to Polish;
- RMS changing/withdrawing procedures;
- Supporting QA Department/Contract Manufacturers with operational activities related to responses to regulatory questions and commitments; providing direct inputs depending on complexity and scope;
- Coordinating regulatory activities with external 3rd Party regulatory service providers;
- Coordinating the registration process of medical devices and food supplements;
- Preparing dossier in NeeS and eCTD through electronic submission software;
- Maintaining current knowledge of existing and emerging regulations, standards or guidance documents;
- Building and maintaining effective relationships with internal and external stakeholders;
- Conducting audits of contract manufacturers.
Regulatory Affairs Specialist
Symphar Sp. Z.o.o.
01.2014 - 12.2014
Junior Regulatory Specialist
Symphar Sp. Z.o.o.
01.2013 - 12.2013
Regulatory Affairs Assistant
Symphar Sp. Z.o.o.
10.2011 - 12.2012
Regulatory Specialist
Novascon Pharmaceuticals
01.2011 - 09.2011
Education
Master of Science - Biotechnology
University of Life Science in Lublin
Lublin06-2010
Master of Science - Cosmetics And Food Supplements
Academy of Cosmetics And Health Care
Warsaw06-2012
Skills
- MS Word, Excel, PowerPoint
- eCTD Office
- Inform CC
- Driving License – B, 2008
- ISO 9000:2001 Certificate
- Auditing expertise
- Teamwork and collaboration
- Attention to detail
- Time management
- Multitasking Abilities
- Task prioritization
- Self motivation
- Global regulatory compliance
Certification
- 2011 - Preparation of application form and complete documentation for variations. Medicinal Products registered in European Procedure (MRP/DCP). Sunset clause procedure/Preparation of application form and complete documentation for variations. Medicinal Products registered in national procedure.
- 2012 - Registration in National Procedure - current requirements.
- 2013 - Local Safety Officer Meeting April 2013, Berlin/Product Information. Assessment of graphic design.
- 2014 - Preparation of documentation for variations. Medicinal Products registered in national and European procedure/Module 2 of dossier. Quality, safety, efficiency/Food supplements – current requirements.
- 2015 - Registration and Bioequivalence study/Annual Registration Summit.
- 2016 - Food supplement and FSMP/Borderline Products/Switch - change legal status.
- 2017 - Annual Registration Summit.
- 2018 - Stability studies of medicinal products/Nitrosamines - new requirements for manufacturers v.1.
- 2020 - Post-approval variations/Generic Product.
- 2022 - Nitrosamines – new requirements for manufactures v.2.
- 2023 - Medical Devices/Module 3 of Dossier.
- 2024 - Review of CMDh guidelines in European procedures/Pharmacovigilance.
- 2025 - Transfer of manufacturing process.
Languages
English
Full Professional
Timeline
Associate Regulatory Manager
Farmak International. Sp. Z.o.o.
01.2025 - Current
Senior Regulatory Affairs Specialist
Symphar Sp. Z.o.o.
01.2015 - 12.2024
Regulatory Affairs Specialist
Symphar Sp. Z.o.o.
01.2014 - 12.2014
Junior Regulatory Specialist
Symphar Sp. Z.o.o.
01.2013 - 12.2013
Regulatory Affairs Assistant
Symphar Sp. Z.o.o.
10.2011 - 12.2012
Regulatory Specialist
Novascon Pharmaceuticals
01.2011 - 09.2011
Master of Science - Biotechnology
University of Life Science in Lublin
Master of Science - Cosmetics And Food Supplements
Academy of Cosmetics And Health Care