Regulatory Affairs Manager

Regulatory Affairs Manager / Remote / 24.43 per hour PAYEWe 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 RoleThis 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 ResponsibilitiesLead 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 ..... full job details .....