Regulatory Strategy and Submissions Manager

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

• Work as an SME for the CTIS portal advising on how to use this system

• 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

• 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:

• 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

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