Your new company

This is a clinical-stage Biotech Company. This company is committed to ensuring culture is at the forefront of their business. They have just raised their Series A.

Your new role

What you'll need to succeed

- Higher degree preferred or equivalent experience
- 10+ years’ experience in biotech or pharma with 7+ years in Regulatory Affairs
- Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.

What you'll get in return

- Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan

- Leading working groups tasked with developing regulatory submissions e.g. IND working group.

- Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overall
-Providing regulatory input on safety documentation e.g. Development Safety Update Report (DSUR), Investigator’s Brochure (IBs)

What you need to do now

Email george.costard1@hays.com

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.