Regulatory Affairs Consultant

3 weeks ago

Slough, United Kingdom Cpl Life Sciences Full time
Job Title:

Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.

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

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