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.

Originally posted on Himalayas