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Work Background
RegunautCo-Founder & CEO
Feb. 2025We build AI-powered regulatory agents and workflows specifically for the pharmaceutical industry.
BIOTON S.A.Director Of Business Operations
Mar. 2021 - Nov. 2022Warsaw, Mazowieckie, Poland• Providing day-to-day operational support to CEO to maximize effectiveness through proactive planning, effective prioritization, appropriate briefings, and facilitate timely execution of initiatives where appropriate
• Coordination of all business operations activities, inclusive of Executive level commitments, selective project management and above site budget oversight
• Work closely with CEO’s direct reports to ensure the effective execution of business operation activities by developing trackng tools, corporate presentations
• Managing and overseeing end-to-end planning and facilitating of LT meeings (inclusive of weekly roundtables, monthly LT meetings)
• Facilitate communication
BIOTON S.A.Regulatory Affairs Manager
Feb. 2020 - Oct. 2022• Leading Regulatory Affairs Team & CMC Team to ensure global submissions and Marketing Authorisation maintenance of biologics and biosimilars containing human insulin in Asia & Pacific, MEA, CIS, Europe & LatAm regions
• Working closely with Business Division to ensure regulatory projects are conducted within budgets and timelines
• Working closely with commercial partners on international markets to align registration strategies, assure compliance and achieve timely results to enable sales
• Working with the team to design Regulatory Databases and implement Regulatory tools (including Dossier Management software, Docubridge, Lorenz)
• Managing the finalization of clinical trial through direct communication and scientific exchange with the CRO and clinical site
• Representing Regulatory Affairs on internal and external development and registration project teams
• Participating in Corporate Leadership Groups and Executive Team meetings to develop strategic planning and contribute to company culture
• Coordinating a comprehensive upgrade of registration dossier performed by an interdisciplinary team of internal and external experts, throughout Modules 2-5 of CTD
BIOTON S.A.Senior Regulatory Specialist
Oct. 2019 - Feb. 2020Warsaw, Masovian District, Poland• Managing Regulatory procedures on International Markets
• Planning and executing of budget for global regulatory activities • Contributing to the writing and editing of regulatory and technical documents
WeatfactoryCo-Founder
Jun. 2017 - Oct. 2018Warsaw, Masovian District, Poland• Designed and built a premium brand in the FMCG sector, focusing on quality and innovation.
• Launched and operated an online shop, expanding the company's reach to a wider customer base.
• Built sustainable sales in both B2B and B2C market sectors, increasing revenue and market presence.
3 TopoleOperations & Branding Lead — Family Business
Jun. 2014 - May. 2025PolandLed operations and brand development in our family business — from implementing lean management processes to shaping the company’s public image. I continue to serve as a strategic advisor, supporting key decisions and acting in a board-level capacity as the business grows. Over the years, I contributed to modernizing and scaling a multimillion-euro operation.
Collège de FranceResearcher
Nov. 2010 - Jun. 2014Paris Area, France1. Rebuilding MTOCs upon centriole loss during mouse oogenesis. Łuksza M, Quequigner I, Verlhac M-H & Brunet S. Dev Biol 382 48-56 (2013).
2. Chromosome structural anomalies due to aberrant spindle forces exerted at gene editing sites in meiosis. Manil-Segalen M, Łuksza M, Kannaan J, Marthiens V, Lane S, Jones K, Terret M-E, Basto R, Verlhac M-H. Accepted at JCB (07.2018)
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