BioTalent are excited to partner with a venture-backed AI enabled biotech focused on precision medicines for neuro and immunological diseases. They are seeking their first in house regulatory leader to develop & lead all regulatory strategies.

Role responsibilities:

• Develop and lead all regulatory strategies, both US and globally.
• Communicate and work with the FDA and global health authorities.
• Plan, prepare and review submissions to regulatory authorities including FDA, EMA and other global health authorities.
• Development planning, (TPP) development, resource planning and risk assessment.

You will bring:

• Over 9 years of experience in Regulatory affairs within the biotech and pharma industry, previous experience in R&D or related field.
• Successful filling experience in the United States and globally.
• Previous experience working with the FDA office of neuroscience would be strongly preferred.
• Proven track record of achieving regulatory successes.
• CDx experience would be highly desirable.

For more information about this opportunity, please apply to the role directly or contact Charlotte Fagan at Charlotte.fagan@biotalent.com