Regulatory Submissions Ass Manager II

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 escalate 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

Learn more about our EEO & Accommodations request here .