Senior Regulatory Affairs Associate - CMC

  • Salary: £35,000 - £58,000
  • REF Number: 00049082
  • Consultant: Amy Lloyd
  • Contact: 01438 842979
  • Date Published: 16.10.2020
  • Sector:
  • Location: US or UK,
  • Discipline:

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

Locations: UK based: London. US based: Pennsylvania

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.

The Role: 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 CMCsubmissions.

Experience needed:

  • 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

Apply: For more information or to apply for this Senior Regulatory Associate CMC position, please contact Amy Lloyd on 01438 870022 or email alloyd@ckclinical.co.uk, quoting job ref 49082.

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

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