Regulatory Intelligence Coordinator

Britwell

3 weeks ago

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Do you have experience in Regulatory Intelligence? Can you manage RIN requirements? If so, this could be the perfect opportunity for you!

We are recruiting for a Regulatory Intelligence Coordinator to join a leading multinational biopharmaceutical client based in Berkshire.

The successful candidate will work with relevant teams on regulatory/guidance requirements through to controlled documents as needed.

This is a contract position, inside IR35, offered initially for 12 months on a hybrid basis.

Responsibilities:

Act as the RIN coordinator.
Review regulations and identify which SMEs should be assigned based on the topic.
Act as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and subsequent studies.
Act as the Audit Host alongside the Auditing team.
Host and coordinate with relevant SMEs and functions on any internal Quality Audit. Assist the assigned SMEs in responding to queries by the auditees.
Work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.Requirements:

Previous experience within Regulatory Intelligence.
Previous experience working with and alongside Audit teams.
Preferably experience handling data sets.
Ability to communicate and coordinate well with others.
Computer literate. Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission. Where the role is marked as Outside IR35 in the advertisement this is subject to receipt of a final Status Determination Statement from the end Client and may be subject to change

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