Job Description We are looking for a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high-quality regulatory submissions across Europe and beyond. This role plays a critical part in ensuring timely approvals, regulatory compliance, and successful study start-up, with a strong focus on EU Clinical Trial Regulation (CTR) and CTIS operations. You will work in a matrix, client-facing environment, collaborating closely with project teams, start-up leads, local regulatory teams, and external authorities.
Key Responsibilities
- Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials, including: Submission strategy, planning, and timeline management
- Tracking approvals against project milestones (GL, RTE)
- Coordinating responses to authority queries within defined timelines
- Lead or support EU CTR submissions via CTIS, including: Preparation, submission, and maintenance of CTIS applications
- Managing CTIS user access and acting as CTIS back-up when required
- Advising internal teams on CTR/CTIS processes and expectations
- Prepare, review, and quality-check core regulatory packages and country-specific submission packages
- Ensure all deliverables comply with applicable regulations, guidance, SOPs, and client requirements
- Provide regulatory guidance to project teams by maintaining up-to-date knowledge of global and EU regulatory requirements
- Liaise with or support local teams in communications with Regulatory Authorities, Ethics Committees, and Third Bodies
- Identify and proactively escalation risks to timelines, quality, or approvals
- Support audits, inspections, and resolution of findings
- Contribute to process improvement initiatives, including SOP development and optimization
- Mentor junior team members and support overall team capability building
Required Qualifications & Experience
- Bachelor’s degree in Life Sciences or a related field (or equivalent experience)
- Minimum 4 years of experience in Regulatory Affairs, Regulatory Submissions, or Clinical Trial Start-up within pharma, biotech, or CRO
- Hands-on experience with EU CTR and CTIS is required, including: Preparing and submitting applications in CTIS, Managing CTIS workflows, timelines, and user access, Responding to CTIS-related authority questions
- Solid understanding of RA, IRB/EC, and Third Body submission processes
- Experience supporting global or regional clinical trials
- Strong organizational skills with the ability to manage multiple submissions and deadlines
- Confident communicator able to work with cross-functional and client stakeholders
At Fortrea, we're all about turning the impossible into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.
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Regulatory Submissions Ass Manager II in Leeds employer: Fortrea
Fortrea is an exceptional employer that offers a rewarding and meaningful work environment, particularly for Senior Technical Designers. With a strong support network, flexible working solutions, and a commitment to employee growth, you will thrive in a collaborative workspace that values diversity and inclusion. Enjoy competitive compensation packages and the opportunity to make a significant global impact while maintaining a genuine work-life balance.
