First Job in Regulatory Affairs Program

Work experience:

• Regulatory Associate Manager in the multinational pharmaceutical company with over 6 years of experience in the industry.
• Managing early development oncology programs (registrational planning and strategy building, leading preparations for EMA scientific advice, ODD, EU PIP etc.).
• Pre-registrational stage: management of clinical trial documentation (substantial, non-substantial amendments of IB/Clinical Protocol/IMPD); managing Response to Questions from Health Authorities; leading preparations for transitions and new applications under EU CTR).
• Post-authorisation stage: performing and being responsible for wide array of procedures for medicinal products registered in the EU (via CP/MRP/DCP procedures) and nationally registered products in Poland, such as: MAAs, renewals, variations, referrals, notifications, gap analysis, withdrawals of medicinal products, leading Response to Questions from Health Authorities, resolving validation enquires; global project management of variations and MAH transfer.
• Providing regulatory recommendations on marketing and promotional materials.
• Maintaining effective and professional communication with Health Authorities and other relevant stakeholders.
• Speaker in multiple conferences for healthcare professionals and pharmacy students in both national and international level; delivering trainings and participant of multiple healthcare conferences, soft and hard skills trainings / workshops.

Education:

• Pharmacy, MPharm at Jagiellonian University Medical College in Cracow, Poland (2017)
• Interdisciplinary Studies in Pharmaceutical Management at Business School, Warsaw University of Technology, Poland (2019)

Achievements:

• Laureate of leadership programme of American Chamber of Commerce “30 Under 30”, 7th edition, 2021- 2022.
• Laureate of programme „Leaders of healthcare sector” of Leslaw A. Paga Fundation, Warsaw, Poland. The main aim of that educational project is to qualify and train the best and open for changes management staff in healthcare sector.
• Soft skills trainer with growing mindset who is so enthusiastic in self-development, effective communication and public speaking improving skills.
• Polish Pharmaceutical Students’ Association (PPSA) – association initiator and the first national president in 2016; EPSA Alumna since 2017.
• Toastmasters- non-profit organization that teaches public speaking and leadership skills – these both encourage me to be AIDIFY SME

Certificates HARD:

• Pharmacoeconomics, Business School, Warsaw University of Technology
• Clinical Trials and drug development, Business School, Warsaw University of Technology
• Selling and marketing of medicinal products, Business School, Warsaw University of Technology
• GMP, Business School, Warsaw University of Technology
• Regulatory Specialist – workshop
• Medical Devices in light of new regulation
• Variation documentation preparation – workshop
• Variations and renewals
• Product information for medicinal products, 2018

Certificates SOFT:

• Thinking Environment Course, 2022
• LEAN Practitioner, 2021
• Project Management Fundamentals, 2021
• Virtual Presentation Skills, 2021
• Toastmaster “Competent Communicator”, 2020
• Trainers Development Camp, 2016