10 regulatory consultants

Experience: Principal Consultant Global Regulatory Affairs · Independent Regulatory Affairs Consultant to Biotech and Pharmaceutical Industry

Principal Consultant Global Regulatory Affairs as an independent regulatory affairs consultant to the biotech and pharmaceutical industry since 2019, and Vice President Regulatory Affairs at Crystalys Therapeutics since 2025. She was also Principal Consultant at NDA Group - an SSI Strategy Company (2017–2020), and her profile cites pharmaceutical development and regulation experience in multinational pharma, biotech and the MHRA.

Experience: President and Principal · Lewis Regulatory Consulting, LLC

President and Principal at Lewis Regulatory Consulting, LLC since 2019; his profile also lists Principal (and President) roles at the firm for 2013–2018 and 2008–2011. He was Vice President Regulatory Affairs at Kolon TissueGene, Inc. (2018–2019) and Executive Director and Head Regulatory Affairs North America at Mitsubishi Tanabe Pharma Development America (2011–2013), and his profile cites industry and FDA experience in development, compliance and global product registration.

Experience: Biopharmaceutical Global Regulatory Affairs Strategy Consultant · RegStrat LLC

Biopharmaceutical Global Regulatory Affairs Strategy Consultant at RegStrat LLC since 2024. His profile also lists Sr. Vice President, Head of Global Regulatory Affairs at Horizon (2022–2024) and Sr. Vice President, Global Head of Regulatory Affairs and Translational Sciences at Acadia Pharmaceuticals (2017–2022), and describes regulatory affairs experience across therapeutic areas including psychiatry and neurology.

Experience: CEO and Principal Consultant in Regulatory Development Strategy · EJConsulting

CEO and Principal Consultant in Regulatory Development Strategy at EJConsulting since 2026, and former Director of Development Consulting and Scientific Affairs at PharmaLex (2021–2024). Her profile says she shapes early Phase 1/2 global regulatory and development strategies, including for advanced therapies such as CAR-T, gene therapies and RNA therapeutics, and she was Senior Director, Global Regulatory Affairs, Team Lead Strategy (EU & RoW) at Genmab (2025–2026).

Experience: Managing Principal · Erskine Mar Consulting LLC

Managing Principal at Erskine Mar Consulting LLC since 2014; her profile describes her as a regulatory affairs executive and consultant who founded the firm and advises primarily small and emerging biotech companies, particularly oncology startups. She was also Director, Senior Advisor, Global Regulatory Affairs - NDD at EMD Serono, Inc. (2010–2014) and a Regulatory Affairs Consultant (2009–2010).

Experience: President Owner Regulatory Consultant · Ensor Pharma Biotech Consulting

President Owner Regulatory Consultant at Ensor Pharma Biotech Consulting since 2025 and Partner at ELIQUENT Life Sciences since 2026; her profile describes her as a strategic regulatory compliance consulting executive and former FDA senior leader. She was also Senior Vice President, Head of Global Strategic Compliance Consulting at Parexel (2022–2024) and Senior Global Managing Director and Vice President, Pharma Biotech Consulting at NSF (2024–2025).

Experience: Founder & Head of Regulatory Affairs Consulting · Nahler RA Consulting | Basel, Switzerland

Founder & Head of Regulatory Affairs Consulting at Nahler RA Consulting since 2022; her profile describes building and leading regulatory affairs functions across Europe and guiding therapies from development to approval through FDA, EMA, MHRA and Swissmedic. She was also Senior Director, Head of Regulatory Affairs Europe at Urovant Sciences International GmbH (2021–2022) and Director, Regulatory Affairs Europe at Arvelle Therapeutics (2020–2021).

Experience: Founder and Principal Consultant · Ramp Regulatory

Founder and Principal Consultant at Ramp Regulatory and Principal Consultant at Scendea, both since 2023, and former Director and Principal Consultant at Scendea (2020–2023). Her profile says her work focuses on strategic and technical consulting in non-clinical and clinical development and regulatory affairs strategy, with experience in pre-market development expectations in the EU, US and UK.

Experience: Global Regulatory Strategy Advisor (EU & US) · Paola Tocchetti Consulting

Global Regulatory Strategy Advisor (EU & US) at Paola Tocchetti Consulting since 2026; her profile says she helps pharmaceutical and biotech companies navigate regulatory complexity and turn development programs into approvals. She was also SVP, Head of Global Regulatory Affairs at Aptuit (Verona) Srl, an EVOTEC Company (2022–2026) and VP, Head of Regulatory Affairs at Aptuit, an EVOTEC company (2021–2022).

Experience: Principal Consultant · Regulatory Science Insights, LLC

Principal Consultant at Regulatory Science Insights, LLC since 2025, and former Vice President, Head of Regulatory Strategy at Alkermes (2023–2025) and Vice President, Head of Regulatory Affairs and Quality at Palleon Pharmaceuticals (2022–2023). His profile says his expertise spans regulatory submissions such as IND, CTA, Orphan Drug, PIP and PSP for small molecule, biologic and gene therapy programs.