ABOUT THIS ROLE

PAREXEL FSP is currently looking for an experienced Regulatory & Submissions Manager to join our expanding team in the UK.

Currently, the position is home-based.

The Clinical Operations Manager COM-R is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

Experience required to be a fit for this role:

Mandatory – Extensive experience in local EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission.
Experience in Independently preparing submissions (CTC supports with documents collection) to both EC and RA.
Experience in ICF preparation using templates.
Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
Experience in validation of translated documents.

We offer exceptional financial rewards, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients

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