Regulatory Scientist – India
Summary:
ICON plc, a leading global provider of clinical research and healthcare intelligence, is seeking a highly motivated and experienced Regulatory Scientist to join our expanding team in India. In this role, you will be responsible for supporting regulatory submissions for Phase 1-3 clinical trials, ensuring compliance with local regulations and international guidelines. If you possess a strong understanding of the Indian regulatory landscape and a passion for advancing clinical research, we encourage you to apply.
About ICON plc:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We partner with pharmaceutical, biotechnology, and medical device companies to accelerate the development of new medicines and therapies that improve lives. With a global team of over 40,000 employees, we deliver a full range of clinical development services from Phase I to post-approval studies.
Job Overview:
As a Regulatory Scientist at ICON, you will play a critical role in navigating the complex regulatory environment in India. You will be responsible for preparing and reviewing regulatory documents, managing submissions through the SUGAM portal, ensuring accurate CTRI registration, and maintaining meticulous documentation. Your expertise will be essential in ensuring the timely and compliant execution of clinical trials.
Key Responsibilities:
- Support regulatory submissions for Phase 1-3 clinical trials in India.
- Prepare and review CT04, CT16, and other CDSCO application documents.
- Manage submissions through the SUGAM portal and ensure accurate CTRI registration.
- Maintain documentation via TMF, CTMS, and Veeva Vault systems.
- Ensure compliance with ICH GCP and NDCT 2019 regulations.
- Collaborate with cross-functional teams (e.g., Data Integrity, Artificial Intelligence, Advanced Clinical Imaging) to ensure alignment and efficient execution of regulatory activities.
- Monitor regulatory updates, toxicity requirements, and evolving guidelines to ensure up-to-date knowledge and compliance.
- Support submission readiness activities and regulatory milestone planning.
- Proactively identify and address potential regulatory challenges.
- Contribute to the development and improvement of regulatory processes and procedures.
Required Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- A minimum of 4 years of regulatory affairs experience, preferably within a Contract Research Organization (CRO).
- In-depth knowledge of CDSCO regulations, SUGAM portal procedures, and CTRI registration processes.
- Proficiency in using TMF, CTMS, and Veeva Vault systems for document management.
- Excellent attention to detail, strong communication (written and verbal), and effective time management skills.
- Thorough understanding of India clinical trial regulations and ICH GCP guidelines.
- Ability to work independently and as part of a team.
- Strong problem-solving skills and the ability to think critically.
Benefits of Working at ICON:
ICON offers a competitive benefits package designed to support the health, well-being, and financial security of our employees and their families. Our comprehensive benefits include:
- Competitive industry salary, commensurate with experience.
- Generous annual leave entitlements to promote work-life balance.
- Comprehensive medical insurance coverage for you and your family.
- Retirement planning benefits to help you secure your future.
- 24/7 access to TELUS Health support services for confidential mental health and well-being support.
- Life assurance coverage to provide peace of mind for your loved ones.
- Optional benefits including childcare vouchers, gym membership discounts, travel subsidies, and more.
- Opportunities for professional development and career advancement within a global organization.
How to Apply:
If you are a highly motivated and experienced regulatory professional seeking a challenging and rewarding career opportunity, we encourage you to apply. Please submit your resume and cover letter through the following link:
[Application Link]
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Join ICON and be part of a team dedicated to improving lives through clinical research and healthcare intelligence.