Advancing Regulatory Science for Transformative Rare Disease Therapies

Chandrashekhar Natarajan MSc FRSC FTORPA is a globally respected regulatory leader with nearly three decades of experience across the pharmaceutical and biotechnology industries. He currently serves as Vice President Regulatory Affairs at Dyne Therapeutics, a Boston based biotechnology company focused on developing transformative therapies for rare muscle diseases. At Dyne, Shekhar leads the development of regulatory strategies across the company’s rare disease portfolio, guiding products from early development through clinical advancement and commercialization.

Over the course of his career, Shekhar has built deep expertise across regulatory affairs, quality, and compliance, supporting the full product lifecycle from preclinical research to global market authorization. His work reflects a strong commitment to strengthening regulatory pathways while ensuring that innovative therapies reach patients efficiently and safely. He is particularly passionate about addressing rare diseases, an area marked by significant unmet medical need, and has consistently advocated for regulatory frameworks that accelerate access to life changing treatments.

Shekhar has played an influential role within leading European industry associations, including EFPIA and EUCOPE. During his tenure with EFPIA, he chaired the India Regulatory Network for several years. In this capacity, he represented EFPIA in strategic meetings between the European Commission, the European Medicines Agency, and the Indian Ministry of Health, contributing to dialogue on emerging regulatory topics impacting the global pharmaceutical sector. His leadership helped strengthen collaboration between European and Indian regulators, fostering greater alignment in regulatory standards and processes.

He has also supported several European Medicines Agency initiatives as an expert industry member, contributing to efforts aimed at enhancing and modernizing regulatory systems across Europe. His insights have been instrumental in shaping discussions around innovation, compliance, and patient centric regulatory reform.

Shekhar’s contributions have received international recognition. He was featured in EUCOPE’s Member Spotlight series, highlighting the pioneering work of Dyne Therapeutics in advancing life sciences innovation and improving patient outcomes. He has been honored with Fellowship of the Royal Society of Chemistry and Fellowship of The Organisation for Professionals in Regulatory Affairs, reflecting his professional excellence and leadership in the field.

In addition, Shekhar serves as a member of the Expert Advisory Group of the British Pharmacopoeia Commission, where he contributes to the development and maintenance of quality standards for medicines. He was recently appointed Chair of the Therapeutic Scientific Committee by the International Rare Disease Research Consortium, further reinforcing his standing as a global thought leader in rare disease research and regulatory science.

Through his strategic vision, collaborative leadership, and unwavering commitment to patients, Chandrashekhar Natarajan continues to shape the future of regulatory science and drive progress in the global rare disease landscape.