About

Shekhar Natarajan is a seasoned biotech leader currently serving as Vice President, Regulatory Affairs and Policy at Dyne Therapeutics, a Boston, USA-based biotech company specialising in rare muscle diseases. Within Dyne, Shekhar is responsible for developing regulatory strategies for the rare disease portfolio of products.

Shekhar has close to three decades of pharma and biotech industry experience covering regulatory affairs, quality, and compliance, supporting the entire life cycle of products, from pre-clinical and clinical development through commercialisation. He is very passionate about his efforts in the healthcare space and has been a strong advocate for Rare Diseases, where there is a huge unmet need.

Shekhar has been very active in EU industry association forums such as EFPIA (European Federation of Pharmaceutical Industries and Associations) and EUCOPE (European Confederation of Pharmaceutical Entrepreneurs), while also supporting global Health Authorities as an industry volunteer in their scientific and technical initiatives.

During his time at EFPIA, Shekhar chaired the India Regulatory Network for several years. As Chair of the India Regulatory Network, he represented EFPIA in meetings between the European Commission (EC), European Medicines Agency (EMA), and Indian Ministry of Health (MoH) on emerging and regulatory topics impacting the pharmaceutical industry.

He is well recognised for his efforts in the field of healthcare and regulatory affairs and was awarded Fellowship of the Royal Society of Chemistry (FRSC) and Fellowship of The Organisation for Professionals in Regulatory Affairs (FTORPA). Shekhar is a member of the Expert Advisory Group (EAG) of the British Pharmacopoeia Commission (BPC). He was also recently appointed by EUCOPE as Chair of the R&D Focus Group and by the International Rare Disease Research Consortium (IRDiRC) as Chair of the Therapeutic Scientific Committee (TSC).