RNDr. Lucie Wallenfels, PhD

Lucie holds a PhD in Immunology and brings a strong scientific foundation, backed by hands-on research experience in molecular biology, oncology, and structural biology. She focuses on medical writing, supporting Synavia’s clients in a broad range of EU regulatory submissions. She specialises in the preparation of briefing documents for scientific advice procedures and Module 2 clinical and nonclinical overviews and summaries. Her portfolio also includes Paediatric Investigation Plans (PIPs), Risk Management Plans (RMPs), OTC legal status justifications, Periodic Safety Update Report (PSURs), updates to SmPCs and PILs, or responses to deficiency letters. She has contributed to projects across diverse therapeutic areas, ensuring alignment with regulatory expectations.

Prior to joining Synavia, Lucie worked at PharmInvent/PrimeVigilance as a Medical Writer with a regulatory focus, where she contributed to a variety of regulatory documents and has gained also foundational knowledge of pharmacovigilance.

Lucie thrives in assignments that require strategic thinking, cross-functional collaboration, and adaptability to complex regulatory challenges. She values clarity, precision, and scientific integrity when translating data into structured and compliant regulatory documents.