📋 Accelerate Clinical Development: Regulatory Scientist - India (Office or Home-Based)
Join ICON plc as a Regulatory Scientist and become the driving force behind successful clinical trial approvals across India. This flexible role offers you the choice of office or home-based work while you navigate India's regulatory landscape to bring innovative therapies to patients faster.
As a world-leading healthcare intelligence organization, we're seeking an experienced regulatory professional to manage CDSCO submissions and ensure compliance with India's evolving clinical trial framework. If you're passionate about regulatory science and want to shape the future of clinical development in India's growing research ecosystem, this is your opportunity to build a meaningful career with flexible work arrangements.
🎯 Your Regulatory Mission: Key Responsibilities
Regulatory Submission Excellence
- Support and execute end-to-end regulatory submissions for Phase 1-3 clinical trials through India's SUGAM portal
- Prepare and review critical application documents including CT04, CT16 forms with precision and accuracy
- Ensure timely and accurate CTRI registrations and maintain compliance throughout trial lifecycle
- Monitor and implement evolving regulatory requirements including toxicity guidelines and NDCT 2019 updates
Compliance & Documentation Mastery
- Ensure strict compliance with ICH GCP guidelines and India's specific regulatory framework
- Manage comprehensive documentation systems including TMF, CTMS, and Veeva Vault
- Maintain meticulous records and archival systems for regulatory inspections and audits
- Stay current with CDSCO updates and implement process changes proactively
Cross-Functional Collaboration
- Collaborate effectively with internal stakeholder groups including DI, AI, and ADCI teams
- Drive submission readiness through proactive planning and clear communication
- Partner with clinical operations to ensure regulatory alignment across study conduct
- Contribute to successful regulatory milestones through strategic preparation and follow-up
⭐ Your Profile: Regulatory Expertise
Essential Qualifications
- Bachelor's or Master's degree in Scientific or Healthcare discipline
- 4+ years regulatory affairs experience, preferably within CRO environment
- Strong knowledge of CDSCO submission processes including SUGAM and CTRI portals
- Comprehensive understanding of ICH GCP and India clinical trial regulations
Technical Competencies
- Hands-on experience with TMF, CTMS, and Veeva Vault systems
- Proficiency in electronic document management and regulatory tracking
- Knowledge of NDCT 2019 requirements and recent regulatory updates
- Experience with clinical trial application preparation and submission
Professional Attributes
- Exceptional attention to detail in regulatory documentation and submissions
- Strong communication skills for effective cross-functional collaboration
- Proactive timeline management with ability to prioritize multiple submissions
- Adaptive learning mindset for evolving regulatory requirements
India-Specific Expertise
- Practical experience with SUGAM portal navigation and submission processes
- Understanding of state-level regulatory requirements alongside central CDSCO approvals
- Knowledge of ethics committee submissions and coordination requirements
- Familiarity with import license applications and regulatory agency interactions
💫 Why Build Your Regulatory Career at ICON?
Impact Patient Access in India
- Play a crucial role in bringing innovative treatments to Indian patients
- Contribute to the growth of India's clinical research capabilities
- Work on diverse therapeutic areas and complex trial designs
- Ensure compliance while accelerating clinical development timelines
Flexible Work Environment
- Choice of office-based or 100% home-based work arrangements
- Modern technology infrastructure for seamless collaboration
- Balance professional responsibilities with personal preferences
- Support for both collaborative office work and focused remote delivery
Professional Growth & Development
- Clear pathway to Senior Regulatory Scientist and Leadership roles
- Exposure to global regulatory strategies and submission requirements
- Opportunities for specialized therapeutic area training
- Access to ICON's global regulatory network and best practices
Competitive ICON India Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with local support
- Generous annual leave with Indian public holidays
- Retirement planning benefits and financial security
- Professional development allowance and certification support
- Flexible benefits tailored to your lifestyle needs
🌟 Regulatory Milestones You'll Drive
- Successful CDSCO application submissions
- Timely CTRI registrations and updates
- Efficient ethics committee approvals
- Compliance with ongoing regulatory requirements
- Preparation for regulatory inspections and audits
✨ Ready to Navigate India's Regulatory Landscape?
If you're an experienced regulatory professional with knowledge of India's clinical trial framework and passion for accelerating drug development, we encourage you to apply. This Regulatory Scientist role offers the unique opportunity to advance your career while ensuring compliant and efficient clinical trial approvals across India.
Apply Now and become ICON's next Regulatory Science expert in India!
