Sandra draws upon her 40+ years of experience and in-depth knowledge of small-molecule and biological product development in regulatory science to support and guide clients at every step of the drug development process (pre-IND to post approval).
Her expertise is in a broad range of therapeutic areas including CNS, Endocrine, Women’s Health, Oncology, Pulmonary/respiratory, Hemostasis, Cardiovascular, GI, Anti-infectives and Anaphylaxis.
A hands-on leader, Sandra is passionate about partnering with clients in preparing submission documents, coordinating processes to prepare teams and lead FDA meetings. Accomplished at writing US regional sections of INDs and NDAs, she especially provides critical reviews of documents within eCTD Modules 1,2 and 5 and provides regulatory guidance and oversight for pharmacovigilance processes as well as leading the establishment and negotiation of annotated labels for marketing applications.
She has direct regular interfacing with the FDA and experience meetings with global health authorities. As part of that process, Sandra leads as well as prepares teams to lead their FDA meetings and prepare submission documentation and also represents multiple clients to FDA as a US/Regulatory Agent. In addition, she serves as Vice President/Head of Regulatory for small startup companies, strategically directing the regulatory development Previously, Sandra was a Professor at Temple University and spent 29 years at Johnson & Johnson’s pharmaceutical sector across a number of senior roles as well as serving as Vice President of Regulatory Affairs at several biotech companies.
Based in our New Jersey office, Sandra has a global role, with a proven ability to define regulatory strategies and achieve regulatory milestones.
