Regulatory Affairs Consultant

3 weeks ago

Slough Berkshire, United Kingdom Cpl Life Sciences Full time

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

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