Elnaz jokar
Senior Manager - Regulatory Affairs Regeneron Pharmaceuticals
Elnaz Jokar, currently serving as Senior Manager of Regulatory Affairs at Regeneron since January 2024, has extensive experience in regulatory affairs across multiple organizations. Elnaz previously held the role of Regulatory Affairs Manager at Biocartis, where responsibilities included regulatory submissions and collaboration with FDA and pharmaceutical partners. Elnaz’s career also includes positions as a Regulatory Affairs Specialist and a Clinical Laboratory Scientist, with a solid academic background, holding a Master’s degree in Regulatory Science from the University of Southern California and a Bachelor’s degree in Microbiology, Immunology, and Molecular Genetics from UCLA.
Seminars
- Traditional regulatory pathway for CDx co-development in Japan
- Companion vs. complementary diagnostics
- Libtayo approval lessons learned
- Examining how PMDA decision-making processes compare with FDA and EMA expectations, and what this means for global CDx and therapeutic development planning
- Identifying practical strategies to align clinical evidence generation, submission timing, and stakeholder engagement to meet both Japanese and international regulatory standards
Moderator:
Staci Kearney, Founder & Chief Executive Officer, Elevation Strategic Development