Regulatory Submissions Ass Manager II

Fortrea; Polska; Sur place; PLN 180 000 - 240 000; Plein temps

Résumé du poste

Fortrea is seeking a Regulatory Submissions Ass Manager II to support global and regional clinical trials through high‑quality regulatory submissions across Europe and beyond.

This role focuses on EU CTR and CTIS operations, working in a matrix, client‑facing environment with project teams, start‑up leads, local regulatory teams, and external authorities. You will ensure timely approvals and regulatory compliance.

Qualifications

• Bachelor’s degree in Life Sciences or 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, including CTIS submissions and workflows.
• Solid understanding of RA, IRB/EC, and Third Body submission processes.
• Experience supporting global or regional clinical trials.

Responsabilités

• Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned trials, including strategy, planning, and timelines.
• Lead or support EU CTR submissions via CTIS, including preparation, submission, and maintenance of CTIS applications.
• Prepare, review, and quality‑check core regulatory packages and country‑specific submission packages.
• Ensure deliverables comply with regulations, guidance, SOPs, and client requirements.
• Provide regulatory guidance to project teams and maintain up‑to‑date regulatory knowledge.

Connaissances

Regulatory submissions

Cross-functional collaboration

Regulatory guidance

Project management

Attention to detail

Client-facing communication

Formation

Bachelor’s degree in Life Sciences or related field (or equivalent experience)

Outils

CTIS system

CTIS workflows

Description du poste

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 escalated 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.