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