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ICON plc, a global leader in clinical research and healthcare intelligence, is hiring a Regulatory Scientist in India. This role is ideal for professionals with experience in CDSCO submissions, SUGAM portal filings, CTRI registration, NDCT 2019 guidelines, and clinical trial documentation.
If you’re looking for a high-impact regulatory affairs career with a top CRO, this is an excellent opportunity.
Key Responsibilities
As a Regulatory Scientist at ICON, you will:
- Support regulatory submissions for Phase 1–3 clinical trials in India
- Prepare and review CT04, CT16, and other CDSCO application documents
- Manage submissions through SUGAM portal and ensure accurate CTRI registration
- Maintain documentation via TMF, CTMS, and Veeva Vault
- Ensure compliance with ICH GCP and NDCT 2019 regulations
- Collaborate with cross-functional teams (DI, AI, ADCI)
- Monitor regulatory updates, toxicity requirements, and evolving guidelines
- Support submission readiness and regulatory milestone planning
Required Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
- 4+ years of regulatory affairs experience (CRO experience preferred)
- Strong knowledge of CDSCO, SUGAM, CTRI processes
- Familiarity with TMF, CTMS, Veeva Vault
- Excellent attention to detail, communication, and time management skills
- Thorough understanding of India clinical trial regulations & ICH GCP
Benefits Offered by ICON
- Competitive industry salary
- Various annual leave entitlements
- Medical insurance for you and your family
- Retirement planning benefits
- 24/7 access to TELUS Health support services
- Life assurance coverage
- Optional benefits including childcare vouchers, gym membership, travel subsidies, and more
How to Apply
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