Barrington James is thrilled to be recruiting for a Regulatory Affairs Manager role on behalf of a groundbreaking client in the life sciences field. If you’re passionate about advancing clinical trials in Europe, have an eye for detail, and want to work with a dedicated, innovative team, this is the role for you!
What You'll Do:
- Lead CTA Submissions – Take charge of preparing and submitting Clinical Trial Applications (CTAs) through EU CTIS and MHRA IRAS portals, playing a vital role in helping get life-saving products to market.
- Ensure Precision – Conduct quality checks to ensure accuracy and compliance in every submission.
- Be the Go-To Expert – Advise on best practices, providing key insights to help your team excel in regulatory processes.
- Manage Communications – Act as the liaison for critical updates and insights on CTA status, making sure the right information reaches the right people, right on time!
- Drive Excellence – Work cross-functionally to manage the entire lifecycle of CTA submissions, from initial preparation to final archival, while testing and refining processes for maximum efficiency.
Why You'll Love This Role:
- Impactful Work – Your contributions will directly support essential regulatory processes that ensure the safety and efficacy of vital health products.
- Cutting-Edge Tools & Technologies – Stay at the forefront of regulatory technology and industry standards.
- Collaborative Environment – Join a global, high-energy team and thrive in a role that values problem-solving, innovation, and proactive thinking.
What We’re Looking For:
- Solid experience with EU CTR and UK clinical trial submissions, and strong project management skills.
- Proficiency in Document Management Systems and Health Authority Portals.
- Mastery of Microsoft Office Suite and SharePoint.
- A degree (BA or BS) plus 2+ years of regulatory operations experience with electronic submissions.
Ready to make a difference? If you're a detail-oriented, regulatory expert who thrives on impactful, fast-paced work, we’d love to hear from you! Apply today and help shape the future of life sciences!
