Zeb Younes

Director, Regulatory Affairs

PharmaLex UK

Zeb Younes has over 20 years of experience in biopharmaceutical development lifecycle from proof of concept through to, and beyond commercialization with both laboratory and desk based experience in process development, purification, formulation, method development, characterisation, validation, comparability, release and stability testing. Zeb has experience with tissue, cell and gene therapies, vaccines and recombinant proteins. Zeb has hands on authored and supported agency discussions for IND/IMPDs, orphan designation applications, BLA/MAA and meets regularly with various global regulators (including in the last year alone numerous meeting with the FDA, EMA, various EU nationals, ANVISA and Health Canada) for scientific advice discussions.

She has also over ten years of management experience and has set up and managed research teams, GMP testing laboratories and operations, developed and implemented lean systems to increase operational efficiency and has participated and led MHRA/FDA and corporate audits. Zeb holds a 1st in Class BSc (Hons) in Medical Biochemistry.

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