Mark this as favouriteRegulatory Affairs Manager

Regulatory Affairs Manager / Remote / £24.43 per hour PAYE

We are seeking an experienced Regulatory Affairs Manager to lead and support complex clinical trial application projects across Europe and beyond. This fully remote contractor role offers the opportunity to work on strategic regulatory initiatives, collaborate with global teams, and guide clients through the evolving EU Clinical Trials Regulation (EUCTR) landscape.

About the Role

This is a strategic, client-facing position focused on pre-approval clinical trial applications, particularly under the EUCTR framework. You will oversee regulatory submissions via the CTIS portal, manage cross-functional collaboration, and provide expert guidance on documentation, timelines, and regulatory strategy.

Key Responsibilities

• Lead EUCTR submissions, including preparation of core packages for Part 1 and coordination with local teams for Part 2.
• Ensure familiarity with redactions and the regulatory distinctions between Part 1 and Part 2.
• Develop and execute regulatory submission strategies, including review of CMC and IMPD data.
• Provide strategic oversight of clinical trial applications, not limited to operational submission tasks.
• Collaborate with country teams on ethics submissions and post-submission maintenance (e.g., notifications, substantial amendments).
• Engage directly with clients to guide documentation requirements, set timelines, and communicate regulatory expectations.
• Review and manage project budgets, ensuring scope alignment and revenue recognition.
• Support global regulatory initiatives and contribute to SOP development and review.
• Mentor junior colleagues and contribute to internal training and development.

What We're Looking For

• Minimum 8 years of relevant regulatory experience in life sciences.
• Proven expertise in EUCTR, CTIS, and clinical trial applications.
• Strong technical writing skills, particularly in compiling IMPD and CMC data.
• Strategic mindset with experience in regulatory planning and client-facing communication.
• Ability to manage multiple projects, with assignments varying based on project size and scope.
• Experience in biotech, cell and gene therapy, or IVD is beneficial but not required.

Bonus Skills

• Experience with regulatory submissions in US, Canada, Latin America, or sub-Saharan Africa.
• Familiarity with regulatory portals such as Swissmedic and ARIS for UK submissions.
• Understanding of pharmacovigilance activities relevant to marketing authorisation transfers.

This is a 6 month Temporary contract with the potential to extend.

__PRESENT__PRESENT

Should you require any support or assistance, please contact your local Gi Group office.

Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.

Gi Group of companies includes Gi Group Holdings Recruitment Ltd, Gi Recruitment Ltd, Draefern Ltd, Excel Resourcing (Recruitment Consultants) Ltd, Gi Recruitment Ltd, INTOO (UK) Ltd, Marks Sattin (UK) Ltd, TACK TMI UK Ltd, TACK International Ltd, Grafton Professional Staffing Ltd, Encore Personnel Services Ltd, Gi Group Staffing Solutions Ltd and Gi Group Ireland Ltd. Gi Group Staffing Solutions Ltd are acting as an Employment Business in relation to this role.

We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website.