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)