Overview

Reference Number: JO-2401-528471
Regulatory Affairs Consultant – CTA/EU-CTR
Rate: Negotiable
Job Type: Permanent
Location: Central London / West End

Regulatory Affairs Consultant – CTA/EU-CTR (freelancer)

6-12 month contract

Poland, Romania, Croatia, Czech Republic, Italy & UK (Fully Remote)

An exciting opportunity to work as a Regulatory EU CTR SME and support several clients with EU CTR submissions. We are currently seeking Regulatory Affairs Professionals on various levels with experience in Clinical Trial Applications (CTAs) under the EU-CTR directive.

Join the team or work on dedicated client projects as a Senior Regulatory Affairs Consultant, Regulatory Affairs Consultant, or Regulatory Affairs Senior Associate. This will be a temporary contract (6-12 months) with the opportunity to potentially go permanent after the contract completion. The role can be home, or office based in various European locations.

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 client 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:

·       Participate in EU-CTR consulting and contribute to its operational implementation

·       Drive EU CTR submissions, amendments, and strategies

·       Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials

·       Act as the main client contact and deliver submission-specific milestones

·       Offer guidance on submissions expertise to clients

·       Facilitate transversal collaboration between departments for the timely delivery of all submissions of complex large clinical trials

Skills and Experience required:

·       University 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

·       Fluency in English is a must (written and spoken), along with proficiency in the local language

For more details please email your CV to lucy.kirkaldy@cpl.com, please note you MUST be based in the right locations.

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