Senior Regulatory Associate

CK Clinical are recruiting for a Senior Regulatory Associate to join a clinical-stage retinal gene therapy company, on a permanent basis.

Locations:
UK based: Hertfordshire or London.
US based: Philadelphia or San Francisco.

The Company:
A developing gene therapy beyond rare disease and using it to treat a leading cause of blindness, dry age-related macular degeneration (dry-AMD). Dry-AMD is the leading cause of permanent vision impairment for people aged 65 and over and there are no approved treatments.

Senior Regulatory Associate Role:
The Senior Regulatory Associate will support in the development, review and execution of regulatory strategy within the regulatory sub-team and the delivery of regulatory activities/submissions necessary to support global product development and registration.

Your Background:

- A BA/BS in the Life Sciences or equivalent work experience is required. Advanced degree advantageous.
- Up to 4 years' experience in regulatory affairs, with experience in biotechnology/biologicals - particularly ATMPs - development gained in industry or service provider environments.
- Experience of European and US regulatory affairs e.g. CTA/IND/MAA/BLA preparation and submissions. Experience with medical devices and in vitro diagnostics a plus.
- Ophthalmology experience would be ideal.

Apply:
For more information or to apply for this Senior Regulatory Associate position, please contact CK Group, quoting job ref 48879.

It is essential that applicants hold entitlement to work in the UK.