Dr. Nathalie Machluf 

Nathalie is a seasoned regulatory affairs leader with over 16 years of experience guiding biologics, vaccines, and pharmaceutical products through all stages of development, registration, and lifecycle management. She is the Founder and Principal Consultant of RCSS – Regulatory Consulting & Scientific Solutions, where she provides strategic regulatory and scientific support to global biotech and pharma companies, helping transform innovation into regulatory success.

Her expertise spans regulatory strategy, CMC , clinical affairs, and global submissions (IND, CTA, BLA, MAA), along with extensive experience preparing for health authority interactions with Agencies including FDA, EMA and Health Canada . She works closely with R&D, CMC, and clinical teams to align product development with regulatory expectations, ensuring efficient, compliant, and timely advancement of programs.

Before founding RCSS, Nathalie was Vice President of Global Regulatory Affairs at SciVac (VBI subsidiary), where she oversaw global regulatory activities in oncology and vaccines, and led both CMC and Clinical Affairs teams across Israel and Canada. She led all CMC activities and collaborated on clinical aspects with the medical team, securing marketing authorizations from the FDA, EMA, and Health Canada across multiple regions.

Earlier  at Teva Pharmaceuticals, she developed her career  in global regulatory affairs, focusing on neurology, gastroenterology, and autoimmune diseases, including extensive consultations with FDA and EMA on pivotal development programs.

Nathalie also gained valuable regulatory and development expertise at Omrix Biopharmaceuticals ( part of Johnson & Johnson), where she managed IND amendments, post-approval submissions, and non-clinical study design in immunodeficiency and infectious diseases.

She has led CMC regulatory strategy, building comprehensive plans to support development and post-approval submissions across the US, EU, Canada, UK, Israel, and emerging markets. She has also contributed to global Phase III trials and designed and conducted a post-marketing efficacy study whose successful results were accepted by FDA, EMA, Health Canada, MHRA and the Israeli Ministry of Health.

With a PhD in Immunology from the Weizmann Institute of Science, Nathalie combines scientific depth with regulatory and clinical acumen. Her work is distinguished by her ability to integrate complex scientific understanding with practical regulatory strategy, enabling faster access to innovative therapies in oncology, immunology, vaccines, autoimmune and rare diseases.