About the job

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

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Responsibilities