ABOUT RCSS
RCSS offers expert regulatory guidance grounded in scientific depth and real-world experience. Founded and led by Dr. Nathalie Machluf—a tumor immunologist by training and a seasoned regulatory affairs professional with over sixteen years of experience in biologics and pharmaceuticals—RCSS supports global drug development with a focus on strategic, science-driven, and compliant regulatory pathways. The consultancy specializes in biologics and new chemical entities (NCEs) across the U.S., EU, Canadian, and Israeli markets.
With a proven track record of supporting early clinical development and leading products from advanced-stage trials through marketing authorization, RCSS delivers hands-on, strategic support, with particular strength in CMC and clinical disciplines. Services span CMC validation study design, clinical development program design, regulatory strategy, health authority interactions, submission preparation, and post-approval activities.
RCSS's approach is practical, rooted in scientific expertise, and focused on helping innovative therapies move forward efficiently and compliantly.
ABOUT DR. NATHALIE MACHLUF
EXECUTIVE PROFILE
With over 15 years of progressive leadership in global CMC Regulatory Affairs and 10 years in Clinical Regulatory Affairs and Operations, Dr. Nathalie Machluf has successfully led regulatory strategies and submissions to key health authorities, including the FDA, EMA, MHRA, Health Canada, Israeli Ministry of Health and others worldwide.
Her expertise spans all phases of product development and commercialization—from early IND/CTA filings through post-approval lifecycle management—across multiple therapeutic areas.
At SciVac Ltd. (a VBI Vaccines subsidiary), Nathalie spent 10 years in senior leadership roles, culminating as Vice President of Global Regulatory Affairs. She led complex global CMC programs in the fields of vaccines and oncology and was instrumental in developing CMC strategies and securing key components of marketing authorizations in major markets. Nathalie also directed cross-functional teams across Israel and Canada.
Prior to SciVac, Nathalie contributed to global regulatory programs at Teva Pharmaceuticals and Omrix Biopharmaceuticals, supporting clinical trials and pivotal submissions in neurology, gastroenterology, autoimmune diseases, and immunodeficiency.
Nathalie’s deep scientific understanding—grounded in her Ph.D. in Immunology from the Weizmann Institute of Science— has been a cornerstone in guiding companies toward optimal regulatory pathways. By leveraging this expertise, she has crafted robust and innovative regulatory strategies that not only address complex compliance requirements but also align with broader corporate objectives. Nathalie’s ability to integrate scientific insights with regulatory frameworks has consistently driven successful milestone achievements aligned with the key corporate goals.
SUMMARY OF EXPERIENCE AND ACHIEVEMENTS
CMC Regulatory Affairs
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Over 15 years of experience in CMC Regulatory Affairs experience spanning clinical development through post-approval lifecycle management.
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Directed global CMC regulatory strategies and activities from IND/CTA submissions through successful licensure by the FDA, EMA, MHRA, and Health Canada.
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Led and participated in more than 10 regulatory consultation meetings on CMC-related topics—including those supporting clinical trial initiation and product licensure—with FDA, EMA, and Health Canada.
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Extensive experience with CMC regulatory submissions supporting clinical development, marketing authorization, and post-approval maintenance across FDA, EMA, Health Canada, MHRA, Israeli Ministry of Health, and other global Agencies.
Clinical Affairs
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10 years of experience in Clinical Affairs, including operations oversight.
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Led the design, execution, and reporting of a Phase IV efficacy clinical trial, with results approved by the FDA, EMA, MHRA, and Health Canada.
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Supported clinical trial operations readiness and conduct for two global Phase III trials across the U.S., EU, and Canada (more than 20 sites).
Leadership & Team Management
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Built and led Regulatory, Clinical Affairs, and Clinical Operations departments in Israel and Canada, providing strategic direction, operational oversight, and team development.
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Provided cross-functional leadership to R&D, Quality Control, and Manufacturing teams in support of regulatory goals and product development milestones.