Clinical Trials Regulatory Associate Manager

🕒 July 29

🌐 Serbia, Portugal, +5 more countries – Remote

🇷🇸 Serbia – Remote 🇵🇹 Portugal – Remote 🇺🇦 Ukraine – Remote 🇭🇷 Croatia – Remote 🇬🇷 Greece – Remote 🇪🇸 Spain – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 54%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Serve as the Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects and programs. • Provide regulatory oversight and strategic guidance to internal and external stakeholders. • Oversee regulatory submissions. • Review scientific and regulatory documentation, conduct gap analyses, and provide recommendations. • Author and/or review key regulatory documents, including Investigational Medicinal Product Dossiers (IMPDs) and clinical trial justifications. • Coordinate and support European centralized submissions and global country submissions. • Ensure project deliverables are completed on time, within scope, and in compliance with regulatory requirements. • Maintain accurate records in internal systems, databases, and tracking tools in accordance with SOPs. • Support business development activities by providing regulatory expertise. • Deliver regulatory training and presentations as required. • Mentor junior team members and contribute to departmental knowledge sharing initiatives.

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field. • Typically 3–5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or clinical research industry. • Up to date experience of working within the EU CTR/CTIS environment and directly overseeing CTIS within Start-Up. • Experience supporting clinical trial submissions and regulatory documentation. • Strong scientific writing, document review, project management, and stakeholder engagement skills. • Advanced knowledge of clinical trial regulations and regulatory submission processes. • Strong analytical and problem-solving skills. • Excellent communication and collaboration abilities. • Ability to work independently and manage multiple priorities in a fast-paced environment.