Kelene Richardson is a Regulatory Affairs Professional with twenty years of pharmaceutical industry experience and a MBA leading a team of regulatory affairs professionals. Possess strong influencing, negotiating and interpersonal skills in building relationships with stakeholders.
Regulatory experience includes leading global regulatory Chemistry, Manufacturing and Controls (CMC) strategies; negotiating directly with the US Food and Drug Administration (FDA), (CBER and CDER); dossier submissions in compliance with electronic Common Technical Documents (eCTD) requirements for post-approval supplements for pharmaceutical and biologics (vaccines) products; and Rest of the World dossiers oversight (Health Canada, EMA, and other Health Authorities).