Senior Global Regulatory Scientist

🔥 3 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Logo of ICON plc

ICON plc

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

• Ensure regulatory deliverables comply with relevant regulations, guidelines, policies and procedures within contractual timelines and budget. • Develop overall and global clinical trial submission strategies with stakeholders, including risk identification and mitigation. • Lead assigned clinical trial Regulatory project teams. • Serve as client point of contact for clinical trial Regulatory deliverables. • Prepare clinical trial Regulatory plans according to project specifications. • Prepare, create, adapt, coordinate, collate and ensure compliance of global core documents. • Track and report submission and approval progress in CTMS, eTMF and other applicable systems. • Perform quality control reviews of clinical trial Regulatory deliverables. • Coordinate submissions to regulatory agencies, central ethics committees and country-level authorities. • Coordinate clinical trial label review and approval. • Manage Regulatory study budgets and identify out-of-scope activities. • Support maintenance of current Country and Regulatory Intelligence. • Provide Regulatory consulting services as needed. • Participate in business or organizational development activities. • Mentor junior team members as needed.

🎯 Requirements

• BSc degree in a scientific field. • 3-6 years’ relevant global regulatory experience in clinical trials for pharmaceuticals. • Good communications and client-facing skills. • Adaptive personality with an agile mindset. • Fluent English. • 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

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