About the role
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.
Originally posted on Himalayas