Harun Sinha has over 20 years of practical, hands-on experience in the pharmaceutical industry in the arenas of Regulatory Affairs, QA, Technical and Manufacturing Services. An independent consultant since 2019, Harun founded Spark CMC Consulting Corp (Spark CMC) aimed at providing CMC regulatory strategy and authoring support for pharma companies of all sizes.

Prior to founding Spark CMC, Harun worked at Regulatory Affairs Consulting companies Genpharm-Pharmalink, Cardinal Health, and PPD as a CMC consultant. In these leadership roles, he provided CMC strategy and Module 3 dossier development support for small and large molecule products. Harun also partnered with clients to manage the lifecycle of established products and expanded clients’ goals to emerging markets. Harun successfully managed large projects and led multiple teams in various global locations during his tenure as a consultant. 

Prior to his consulting years, Harun gained experience in the fields of generics, consumer health, medical devices and pharmaceuticals, and a variety of dosage forms including solid orals, injectables, liquids and medical devices. Harun worked at companies GlaxoSmithKline Consumer Health, Pfizer, AstraZeneca, and Alphapharm (a Mylan family company in Sydney, Australia). Harun has worked globally and assisted in expanding many companies’ footprints by supporting registration activities. 

Harun has a Postgraduate degree in Pharmaceutical Sciences, from the University of Sydney, Sydney, Australia (2002) and a Bachelor of Science Degree in Biology, from the University of North Carolina, in Charlotte (1998).  Click to Follow Harun’s Linkedin.