Company: Merck & Co.
Job title: Regulatory Affairs Director, Companion Diagnostics
Sid Mathur is a subject matter expert in companion diagnostic (CDx) regulatory affairs, with hands-on experience at both pharmaceutical and diagnostic companies. Sid distills and communicates IVD regulations and requirements to internal Merck colleagues. Sid represents Merck in interacting with diagnostic (Dx) partners to align on regulatory strategy and content of major deliverables like PMAs/IDEs/pre-submissions, leveraging his strong cross-disciplinary skills. Sid has been Merck’s regulatory contact with Dx partners for a majority of the CDx submissions and approvals for a variety of biomarkers. In past roles at Dx companies, Sid has led regulatory submissions for CDxs, infectious disease assays and participated in the development of novel IVDs.