Brenda Rascon

Senior Consultant

Brenda is skilled in the development of biologics, preparation of submissions for biologics, and regulatory approval pathways.

Brenda’s regulatory knowledge spans various phases of product life cycle, including early-, mid-, and late-stage product development, dossier compilation and submission, response preparation, product approval, launch, and post-approval procedures. In addition, she has led pre-submission meetings and response clarification meetings during regulatory approval procedures.

Prior to joining Biopharma Excellence, Brenda served as Director Regulatory Affairs and was a member of the Management Team at Cinfa Biotech, where she previously held two other regulatory roles. During her tenure at Cinfa Biotech, she led the EMA MAA submission and approval of the company’s first product, an oncology biosimilar. As Director Regulatory Affairs, Brenda had the pleasure of leading the Regulatory Affairs team and guided the strategic planning and management of regulatory procedures and interactions, in addition to supporting due diligence activities for product licensing.

Before her time at Cinfa Biotech, Brenda held two roles at Sandoz. In her most recent role, she worked as a Regulatory CMC Manager in the Global Regulatory Affairs department for Biopharmaceuticals. In her capacity as a Regulatory CMC Manager, she wrote IMPDs, quality sections of INDs, IBs, BBs, BLAs, and MAAs of complex biologics, and collaborated with biopharmaceutical technical development teams. Before that, Brenda developed methods for the characterization of biologics in the laboratory and reviewed eCTD modules.     

Prior to entering the pharmaceutical industry, Brenda was active in academic research and is a published author in several peer-reviewed publications. She has been a speaker at international conferences and garnered two presentation awards. She holds a PhD in biology.