Regulatory Submission Manager

🕒 August 31

🌐 Poland, Romania, +2 more countries – Remote

🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇭🇺 Hungary – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 23%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Drive global submission management strategy and activities for assigned protocols • Partner with study teams and manage required regulatory activities, standards and deliverables associated with CTA submission development • Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, assess impact, and present global submission delivery status • Support and lead global team efforts to ensure high-quality, compliant submission components • Liaise with Sponsor Core team, SSU and Study Management regarding essential core and local documentation across HA and EC submission and translation processes • Prepare, review and support Sponsor submissions to HA/Regional CTA Hub to obtain clinical trial authorizations and approvals • Coordinate translations for core submission documents • Manage compilation and core package build, contributing to CTA and authoring documentation • Process incoming requests for information by monitoring the RFI mailbox and CTIS portal, reporting RFIs to study teams, and coordinating responses • Process payments involved in regulatory submissions • Act as local country liaison when required • Escalate, inform, and resolve issues impacting submission builds or global submission delivery logistics • Discuss dossier requirement interpretation with relevant Sponsor SMEs

🎯 Requirements

• Extensive experience with CTIS for document uploads and/or Veeva is required • B.S./B.Sc in Pharmacy, Life Sciences, Business or Information Technology is desirable • Equivalent relevant professional experience will be considered • In-depth understanding and proven execution of CTA and Central Ethics processes • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways