ICON hiring Clinical Trial Regulatory Scientist Jobs

ICON Clinical Research India Private Limited; Chennai District; On-site; INR 1,200,000 - 2,600,000; Full time

Job summary

ICON plc in India invites a Regulatory Scientist to support regulatory submissions and compliance for clinical trials across Phase I–III in India. You will leverage CDSCO knowledge and SUGAM/CTRI systems, with emphasis on timely documentation.

The role requires 4+ years in regulatory affairs, preferably in a CRO, and a life sciences degree. Location options include Bangalore and Chennai, with work-from-office or home-based arrangements.

Qualifications

• Bachelor's or master's degree in a scientific or healthcare discipline.
• Minimum 4+ years of hands-on regulatory affairs experience.
• CRO experience preferred.
• Experience with CDSCO submissions, SUGAM portal, and CTRI.

Responsibilities

• Support regulatory submissions for Phase I–III clinical trials in India.
• Prepare, review, and submit CT04, CT16, and other regulatory documents through the SUGAM portal.
• Ensure accurate CTRI registrations and updates.
• Manage regulatory documentation, tracking, and archival activities using TMF, CTMS, and Veeva Vault systems.
• Ensure compliance with ICH GCP guidelines, CDSCO requirements, and NDCT 2019 regulations.
• Collaborate with cross-functional teams to support submission readiness.
• Monitor regulatory updates, changes in toxicity requirements, and evolving Indian clinical trial guidelines.
• Identify regulatory risks and contribute to mitigation strategies.
• Maintain audit-ready documentation and support inspections.
• Communicate regulatory timelines, milestones, and requirements clearly to internal stakeholders.

Skills

ICH GCP knowledge

CDSCO submissions

CTMS / TMF / Veeva Vault experience

SUGAM portal submissions

Regulatory documentation & timelines

Education

B.Pharmacy

M.Pharmacy

Pharm.D

MSc Clinical Research

MSc Biotechnology

MSc Microbiology

MSc Biochemistry

BSc Life Sciences

BSc Biotechnology

BSc Microbiology

BSc Biochemistry

MBBS

Tools

TMF

CTMS

Veeva Vault

SUGAM portal

Job description

Regulatory Scientist Vacancy for Life Sciences Graduates - ICON India

ICON hiring Regulatory Scientist with 4+ years experience. Life sciences graduates eligible. Locations: Bangalore, Chennai.

ICON is expanding its regulatory affairs team in India and is currently hiring experienced Regulatory Scientists to support clinical trial submissions and regulatory compliance activities. This role offers a strong opportunity for regulatory professionals who want to work with a global clinical research organization, contribute to innovative drug development programs, and grow their careers in regulatory affairs within a CRO environment. The position is open for professionals willing to work from office or home, with locations including Bangalore and Chennai.

Company Overview

ICON plc is a globally recognized healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to advance clinical development.

ICON is known for its strong regulatory expertise, robust compliance culture, and deep understanding of global and regional regulatory frameworks. In India, ICON plays a critical role in supporting clinical trials under CDSCO regulations, NDCT 2019, and ICH GCP guidelines. The organization consistently invests in talent development, digital regulatory systems, and process excellence, making it a preferred employer for regulatory affairs professionals seeking long-term career growth.

Job Role & Responsibilities

As a Regulatory Scientist at ICON, you will be responsible for supporting regulatory submissions and compliance activities for clinical trials conducted in India. This role directly contributes to the successful initiation and progression of Phase I to Phase III clinical trials by ensuring timely and accurate regulatory documentation.

Key Responsibilities

• Support and execute regulatory submissions for Phase I, II, and III clinical trials in India
• Prepare, review, and submit CT04, CT16, and other regulatory application documents through the SUGAM portal
• Ensure accurate and timely CTRI registrations and updates
• Manage regulatory documentation, tracking, and archival activities using TMF, CTMS, and Veeva Vault systems
• Ensure compliance with ICH GCP guidelines, CDSCO requirements, and NDCT 2019 regulations
• Collaborate with cross-functional teams including Data Integrity, Clinical Operations, and Regulatory Intelligence to support submission readiness
• Monitor regulatory updates, changes in toxicity requirements, and evolving Indian clinical trial guidelines
• Proactively identify regulatory risks and contribute to mitigation strategies
• Maintain audit-ready documentation and support internal and external inspections
• Communicate regulatory timelines, milestones, and requirements clearly to internal stakeholders

This role requires strong attention to detail, regulatory intelligence, and the ability to manage multiple submissions simultaneously while meeting strict deadlines.

Eligibility / Qualifications

Educational Qualifications

Candidates must possess a bachelor's or master's degree in a scientific or healthcare-related discipline.

Accepted Education Backgrounds:
B.Pharmacy, M.Pharmacy, Pharm.D, MSc Clinical Research, MSc Biotechnology, MSc Microbiology, MSc Biochemistry, BSc Life Sciences, BSc Biotechnology, BSc Microbiology, BSc Biochemistry, MBBS, or equivalent scientific qualifications.

Experience Requirements

• Minimum 4+ years of hands-on regulatory affairs experience
• Prior experience in a CRO environment is strongly preferred
• Proven experience with CDSCO regulatory submission processes
• Practical knowledge of SUGAM portal submissions and CTRI registrations

Technical & Regulatory Skills

• Strong understanding of ICH GCP guidelines
• In-depth knowledge of Indian clinical trial regulations including NDCT 2019
• Experience working with electronic systems such as TMF, CTMS, and Veeva Vault
• Ability to interpret regulatory guidelines and apply them to clinical trial submissions
• Excellent documentation, communication, and time management skills

Location & Salary

Job Locations

• Bangalore
• Chennai

This role offers flexibility with office-based or home-based working options, depending on project requirements and business needs.

Frequently Asked Questions (FAQs)

Who can apply for the Regulatory Scientist role at ICON?

Candidates with a bachelor's or master's degree in pharmacy, life sciences, biotechnology, or related healthcare disciplines and at least 4 years of regulatory affairs experience can apply.

Is CRO experience mandatory for this role?

CRO experience is preferred but not mandatory. Strong experience with CDSCO submissions, SUGAM portal, and CTRI is essential.

What regulatory systems will I work with?

You will work with TMF, CTMS, Veeva Vault, SUGAM portal, and CTRI systems as part of regulatory submission and compliance activities.

Is this a remote or office-based role?

This role offers flexibility and may be office-based or home-based depending on project and operational requirements.

What is the career growth scope at ICON?

ICON provides global exposure, structured career paths, and opportunities to grow into senior regulatory roles, regulatory strategy positions, and leadership roles within clinical research.