Shekhar Natarajan MSc FRSC FTOPRA

Candidate |President Elect

A passionate biotech leader with over 25 years of industry experience across regulatory affairs, policy, and advocacy. Currently Vice President of International Regulatory Affairs and Policy at Dyne Therapeutics, a biotechnology company focused on rare neuromuscular diseases.

Chair of the Therapies Scientific Committee of the International Rare Disease Research Consortium (IRDiRC) collaborating with regulators, industry leaders, and patient organisations to identify and address scientific and regulatory barriers to rare disease therapy development.

Chair of the R&D Focus Group at European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), an EU trade association where I contribute to high-level regulatory and policy discussions impacting the lifecycle of innovative medicines in the rare disease and orphan drug sector. As part of EUCOPE, I support the European Medicines Agency (EMA) as an industry expert through participation in EMA task force and focus groups. Also, a member of the Expert Advisory Group (EAG) at the British Pharmacopoeia Commission.

Throughout my career, I have remained committed to advancing the regulatory profession through active leadership in regulatory, scientific, and policy initiatives. As President-Elect, I would leverage this experience and network to support TOPRA’s strategic objectives and long-term vision.

I am deeply aligned with TOPRA’s mission to advance the regulatory profession through high-quality education, guidance, and advocacy. As President Elect, I would aim to strengthen existing partnerships and explore new collaborations; maintain focus on key regulatory developments like EU General Pharmaceutical Legislation, the Biotech Act, and Platform Technologies; and support sustainable growth through geographic expansion and by leveraging my networks.

I will work closely with the Board, CEO, volunteers, and members to support continuity, stability, and effective governance whilst exploring opportunities to drive growth. I view the President Elect role as a key connector within the organisation linking organizational priorities with member needs. A core focus will be maintaining and enhancing TOPRA’s reputation for delivering best-in-class regulatory education and training.

I am committed to upholding TOPRA’s values of trust, inclusivity, and excellence. I will support initiatives that strengthen diversity and inclusion while ensuring that TOPRA continues to deliver relevant, high-quality content that reflects the evolving needs of its global membership.