Chandrashekhar Natarajan
Vice President, Head of EU & International Regulatory Affairs Dyne Therapeutics, USA
Bio
Chandrashekhar Natarajan is currently Vice President- Regulatory Affairs at Dyne Therapeutics, a Boston, USA based biotech company specializing in rare muscle diseases. Within Dyne, Shekhar is responsible for developing regulatory strategies for rare disease portfolio of products from pre-clinical and early clinical stage to Ph3 and eventual marketing authorisation approval.
Shekhar has close to three decades of pharma/biotech industry experience covering regulatory affairs, quality and compliance supporting entire life cycle of the product (i.e. pre-clinical, clinical and commercialization) and has worked across many therapeutic areas including Neuroscience and Neuromuscular most recently. Last 10 years have been predominantly working on rare disease products. Shekhar is very passionate about his efforts in the healthcare space and has been a strong advocate for Rare Diseases where there is huge unmet need. He believes every patient should have access to life-saving therapies and no disease should be left untreated.
Shekhar is also working closely with EU regulators and industry associations (e.g. EFPIA, EUCOPE) as industry volunteer in their efforts to create awareness around rare diseases and regulatory reliance mechanism in the emerging economies. He has represented EFPIA on number of high-level regulatory dialogues involving European Commission, European Medicines Agency and Indian Ministry of Health (MoH).
He is well recognized for his efforts in the field of Healthcare and Regulatory Affairs and was awarded Fellowship of Royal Society of Chemistry (FRSC) and Fellowship of The Organisation for Professionals in Regulatory Affairs (FTORPA).
He has been appointed by Medicines and Healthcare Products Regulatory Agency (MHRA, UK) as Member of British Pharmacopoeia Commission’s Expert Advisory Group (EAG) in Jan 2024.
He was also appointed by the International Rare Disease Research Consortium (IRDiRC) as Expert Member of Regulatory Convergence Task Force in February 2025.
Personal Quote:
“Shekhar is a strong advocate in the fight for rare diseases where there is huge unmet need and believes every patient should have access to life saving therapies and no disease should be left untreated. - Chandrashekhar Natarajan”