Job Description
Job Description
Job Title: Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)
Job Type: 12-month contract
Location: 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. You will serve as the main point of contact and be responsible for delivering submission-specific milestones while offering guidance on submission strategies. 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. Your role may also involve serving as a Clinical Trial Submission Coordinator/Lead, overseeing complex large clinical trial submissions.
Responsibilities:
- Lead/support all CTR initial submissions, transitions, amendments, and re-submissions
- Prepare all CTR-related documentation and be responsible for uploading this to the CTIS portal
- Act as an SME for the CTIS portal advising on how to use this system
- Participate in EU-CTR consulting and contributing to its operational implementation
- Drive EU CTR submissions, amendments, and strategies
- Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials
- Offer guidance on submissions expertise to junior team members
- Facilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials
Skills and Experience required:
- A degree in a scientific discipline
- Background in clinical trial management
- Experience in Regulatory Affairs
- Good level of knowledge of Clinical Trial Submissions on a local and regional level
- Working knowledge of submissions under EU-CTR directive
- Solution-oriented and problem-solving skills
- Customer-oriented and able to work in a team as well as autonomously
- Fluent in English is a must (written and spoken)
You must be able to be based on site 3x a week in Berkshire, UK, and have the FULL right to work in the UK. For more information or to apply please reach out to lucy.kirkaldy@cpl.com