Dr Gabriel Bohl FTOPRA

Candidate | Director

Current position and relevant professional experience:

I am Director, Regulatory Affairs at ICON plc, where I lead global regulatory CMC strategy and delivery for medicinal product development programmes. I hold a PharmD and MSc and have broad experience across biologics, advanced therapies, cell and gene therapies, oligonucleotides, small molecules and drug-device combination products. My work spans phase-appropriate development through marketing applications, including INDs, BLAs and MAAs, and involves advising clients on complex CMC risks, agency interactions, submission strategy and inspection-ready documentation across multiple regions. Previously, I have been working in regulatory affairs in a large pharma and as a CMC assessor in a health agency.

Current or previous involvement in TOPRA activities:

I have been a TOPRA member for over 20 years, have held Fellow status (FTOPRA), currently leading Topra IN France, and received a TOPRA Nomination – Distinguished Service Award - in May 2023. Throughout this time at TOPRA, I have actively contributed to the organisation through webinar leadership and participation, authorship of TOPRA Rapporteur articles, and engagement in specialist communities, including the CMC and Biotechnology groups. TOPRA has played an important role in my professional development, and I have continuously drawn on its regulatory resources, networks, and knowledge-sharing activities to support lifelong learning and professional excellence. I am also actively involved in the French TOPRA community, where I help lead local activities and support the continued growth and engagement of our membership.

Having benefited greatly from TOPRA throughout my career, I would now like to contribute more actively to the organisation's future development. I am keen to bring my extensive global regulatory experience to TOPRA's governance, strategic initiatives, professional development programmes, and member engagement activities. I would particularly welcome the opportunity to support key initiatives, contribute to strategic discussions, participate in decision-making, and help further strengthen TOPRA's position as the leading professional organisation for regulatory affairs professionals worldwide.

As a regulatory leader with extensive international experience across biologics, advanced therapies, combination products, and global regulatory strategy, I am eager to contribute this expertise to TOPRA's governance and future direction. My goal is to help shape initiatives that support member development, strengthen the regulatory profession, and expand TOPRA's impact across Europe and globally.

Personal statement:

I am standing for the TOPRA Board because I believe the regulatory profession needs a strong, forward-looking, and internationally connected voice as science, technology, and regulatory frameworks continue to evolve. My priorities would be to enhance member value, support professional development across all career stages, and strengthen engagement within our diverse global community.

I am particularly passionate about advancing practical regulatory approaches for emerging technologies, including advanced therapies, combination products, and digital innovation. I also see significant opportunities for TOPRA to lead thoughtful discussions on the responsible use of artificial intelligence and modern knowledge-sharing practices, while safeguarding scientific rigor, ethics, and public trust.

As a collaborative and pragmatic leader, I would contribute to sound governance, strategic thinking, and effective decision-making. My goal would be to help ensure that TOPRA remains relevant, inclusive, influential, and responsive to the evolving needs of both its members and the wider regulatory profession.