Regulatory Submissions Ass Manager II
About the role
Regulatory Submissions Ass Manager II
timely approvals, regulatory compliance, and successful study start‑up
strong focus on EU Clinical Trial Regulation (CTR) and CTIS operations
matrix, client‑facing environment
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
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 .
Not included in the source posting: benefits.
Who can apply
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