Regulatory Affairs Clinical Research

Working in a CRO (Clinical Research Organisation) means working on large projects simultaneously. The regulatory filing for every stage of the clinical trial needs to be looked after for progress on the drug to be made. Below is an example Spec for a Senior role in a CRO:

Key Responsibilities

• Liaise directly with regulatory bodies such as EMA & National Competent Authorities and you will maintain relations with key contacts
• Work as part of the EMEA Regulatory team.
• Evaluate data, review documentation and support/prepare documentation for medicinal products and medicals devices, as appropriate, for all stages of product development i.e. CTA through to life cycle maintenance
• Maintain an accurate record of the time and direct costs associated with each project for which you are responsible and where appropriate produce status reports.
• You will support the Regulatory Project Lead and dependent on the size of and nature of the project assigned, you may act as the Regulatory Project Lead and you will deal directly with the sponsor and Regulatory Agencies
• Control all project related documentation either in paper or electronic form.

Skills / Experience

• Must have 4-5 Yrs in a similar position.
• Must have a science degree in a related field.
• Knowledge of European guidelines and be able to review and evaluate CMC, Pre-Clinical and/or Clinical data in compliance with the relevant guidance.
• Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner.