CK Clinical are recruiting for a Senior Regulatory Associate - CMC, to join a clinical-stage retinal gene therapy company, on a permanent basis.
UK based: London.
US based: Pennsylvania
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.
The Sr. Regulatory. Associate - CMC Gene Therapy, will manage the CMC regulatory submissions throughout the lifecycle with minimum supervision, with responsibility for the authoring, reviewing, compiling and execution of all regulatory CMC submissions.
- Track record of excellence in CMC regulatory affairs
- Experience working with biologics, Gene therapy experience preferred
- Bachelor\'s degree in Life Sciences or relevant equivalent experience. Advanced Scientific or Process Engineering degree is desirable
- Ability to manage multiple projects/submissions
- Strong oral skills, along with technical writing editing skills and a high attention to detail
- Comprehensive understanding of FDA, EMA and ICH requirement
- Experience with delivery of regulatory submissions in eCTD format
- Must be able to work independently as well as in a matrix team setting, working alongside regulatory affairs, CMC and quality assurance
Quote job ref 49082.
It is essential that applicants hold entitlement to work in the UK.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Amy Lloyd
- Phone: 01438 743047
- Reference: 49082
- Posted: 16th October 2020
- Expires: 13th November 2020