Maren Von Fritschen

Maren von Fritschen is a trusted and influential leader in Regulatory Policy and Affairs, renowned for her diplomacy, stakeholder connectivity, and ability to build consensus across the EU healthcare landscape. With over 20 years of experience in the life sciences and healthcare sector, she has shaped policy, driven regulatory innovation, and delivered forward-looking strategies at the highest levels.

Her extensive career spans senior leadership, governance, and high-impact project delivery. Most recently, Maren served as Head of Regulatory Policy Europe at Moderna, where she established the EU regulatory policy function and led strategic engagement for platform technologies. At EUCOPE, she positioned the association as a respected policy voice at the EMA. As Vice President and Partner at PharmaLex, she played a key role in scaling the company from a start-up into a global regulatory consultancy. She also founded AddOn Pharma, advising clients across healthcare on regulatory strategy, R&D support, and advocacy.

Maren has a proven track record of influencing and connecting high-level stakeholders across European institutions, EMA/HMA/CMDh, and multi-stakeholder platforms. In 2021, she was honoured with the DIA Global Inspire Award – Global Connector for her outstanding contributions in building impactful cross-sector relationships and advancing regulatory dialogue.

In academia, she developed and teaches the Regulatory Affairs & Drug Development MSc module at the University of Applied Sciences Berlin, mentoring international students. She is a frequent speaker, moderator, and trainer at global forums including DIA, TOPRA, and GPRAS, and actively contributes to advisory boards and EU-funded initiatives.

Bringing cultural agility, strategic vision, and a results-driven approach to every engagement always delivered with integrity and a touch of humour. Maren continues to shape the future of regulatory policy in Europe and beyond.