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 Description

• Minimum 3 years’ relevant regulatory experience
• Read, write and speak fluent English
• Travel less than 10%
• Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Ensure regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles




• Manage regulatory deliverables independently including complex studies with some oversight from leadership
• Advanced knowledge of ICON’s SOPs/WIs, ICH, GCP and appropriate regulations
• Advanced knowledge of ICON systems applicable to role
• Regulatory functional team lead, overseeing the assigned clinical trial regulatory project team
• Development of overall and global clinical trial submission strategy according to project requirements in collaboration with stakeholders
• Preparation/development/review/finalisation of regulatory plan according to project requirements
• Prepare/create/adapt/coordinate/collate/review core documentation considering strategic, scientific and therapeutic area principles in addition to study requirements
• Attend internal and external project team meetings representing Regulatory
• Coordinates clinical trial submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and a

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