Director Of Regulatory Affairs

Role:

Director/Senior Director of Regulatory Affairs

Mid-West Region

Company Description:

We are partnered with a non-profit organization committed to alleviating symptoms of depression, anxiety, and other mental health disorders. With the backing of a multi-national biotech organization, the team is conducting FDA and global preclinical and clinical psilocybin trials. As they rapidly approach their first NDA, the team is seeking a Regulatory strategist to lead the team, manage CRO vendors, and successfully commercialize the first psilocybin-based treatment.

Role Description:

This is an onsite position where the ideal candidate will visit the facility 3-4 times per week.

This team is looking for a Director/Senior Director of Regulatory Affairs who will be responsible for the preparation, strategy implementation, and execution of FDA and other global health authority (NDA/MAA) regulatory filings. You will also be responsible to make hiring decisions and to manage the existing Regulatory group of 2.

Qualifications:

• Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
• A passion for the psychedelic and mental health industry
• Bachelor’s degree is required; advanced degree is preferred.
• Both clinical and CMC experience is desired
• Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma

If interested, please apply directly or reach me at [email protected].