Senior Director/ Director Regualtory Affairs

Posted 14 February 2023
LocationSouth San Francisco
Job type Permanent
Contact NameChristina Smith

Job description

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