Back to jobs
Senior Director/ Director Regualtory Affairs
- Posted 14 February 2023
- LocationSouth San Francisco
- Job type Permanent
- Contact NameChristina Smith
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.
- 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.firstname.lastname@example.org