Regulatory Affairs Consultant - Slough, Berkshire, United Kingdom - Cpl Life Sciences

Description

Job Description Job Title:
Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)
Job Type: 12-month contract
Berkshire, UK – Hybrid

Pay Rate:
£65-75 per hour (PAYE)

We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis.

You will work as a Regulatory EU CTR SME and support several EU CTR submissions.

As a Regulatory Affairs Professional, you will assume a crucial role in providing leadership and expertise in all regulatory and submission-related aspects of clinical trials.

Additionally, you will actively participate in EU-CTR consulting and contribute to the operational implementation aspects of the EU-CTR directive, ensuring effective collaboration between departments.

Lead/support all CTR initial submissions, transitions, amendments, and re-submissions
Participate in EU-CTR consulting and contributing to its operational implementation
Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials
Offer guidance on submissions expertise to junior team members
A degree in a scientific discipline
Experience in Regulatory Affairs
Good level of knowledge of Clinical Trial Submissions on a local and regional level
Fluent in English is a must (written and spoken)