Regulatory Affairs Associate

Salary

Competitive

Location

Reading

Job Type

Contract

Reference No: 0064I00001FV3E3QAL

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Key points about this job

  • Preparing, submitting and looking after RA, IEC and any other submissions required
  • Providing submission strategy to the Global Regulatory Lead
  • Ensuring Insurance Certificates, Country Specific Informed Consent Forms and other patient documentation adhere to country requirements
  • Reviewing translations of clinical supply labelling to ensure it meets local requirements
Job Description

This is an hourly rate contract position (initially 6months) with one of our fast growing partners. It is Reading based with some home working.

This position will be responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure timelines are met in the UK and Ireland. This position works closely with the Global Regulatory Lead and Start-up Lead, communicating submissions status’ and mitigating risks.

Position responsibilities:

  • Preparing, submitting and looking after RA, IEC and any other submissions required.
  • Providing submission strategy to the Global Regulatory Lead
  • Ensuring Insurance Certificates, Country Specific Informed Consent Forms and other patient documentation adhere to country requirements
  • Reviewing translations of clinical supply labelling to ensure it meets local requirements

For further information please get in touch with Natalie Jones via [email protected]

Reference No: 0064I00001FV3E3QAL

Apply for this job

Hiring Manager(s)

Natalie Jones
Head of Regulatory Affairs Recruitment at Linkfield Life Sciences
email: [email protected]