Senior Global Regulatory Scientist- Office based- India
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Job Responsibilities:

• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles.
• Developing the overall and global clinical trial submission strategy in accordance with the project requirements in collaboration with stakeholders including proactive identification and mitigation of risks, as applicable.
• Regulatory function team lead overseeing the assigned clinical trial Regulatory project team.
• Point of contact for clients for clinical trial Regulatory deliverables.




• Preparation of clinical trial Regulatory plan in accordance with project specifications.
•Preparation/creation/adaptation/coordination/collation/compliance of global core documents considering strategic, scientific and therapeutic area principles in addition to study requirements.
• Tracking and reporting of submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents.
• Performing Quality Control review of clinical trial Regulatory deliverables in accordance with applicable process.
• Coordinating submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and all other country-level submissions in collaboration with stakeholders, overseeing the assigned Regulatory project team.
• Coordination of clinical trial label review/approval according to project specifications.
• Managing Regulatory study budget, proactively identifying out of scope ac

📌 Senior Global Regulatory Scientist (Bengaluru)
🏢 ICON
📍 Bengaluru