ICON Hiring Clinical Trial Regulatory Scientist Jobs in India for life sciences professionals with CDSCO experience and global clinical research exposure.
Job Category: Regulatory Affairs / Clinical Research
Job Type: Full Time
Experience Required: 4+ Years
Qualification: Pharmacy / Life Sciences Graduates
Locations: Bengaluru, Chennai
Work Mode: Office-Based or Home-Based (Project Dependent)
Job Status: Verified Job
About the Company
ICON Clinical Research India Private Limited is part of ICON plc, a globally recognized healthcare intelligence and clinical research organization. ICON partners with pharmaceutical, biotechnology, and medical device companies to support end-to-end clinical development, from early-phase trials to post-marketing studies.
With operations in more than 40 countries, ICON is known for its strong regulatory expertise, compliance-driven culture, and deep understanding of global and regional regulatory frameworks. In India, ICON plays a key role in managing clinical trial regulatory submissions under CDSCO, NDCT 2019, and ICH-GCP guidelines, offering excellent career growth opportunities for regulatory professionals.
Job Details
- Job Title: Regulatory Scientist
- Department: Regulatory Affairs – Clinical Trials
- Employment Type: Full Time
- Job Locations: Bengaluru, Chennai
- Experience Level: Mid-Senior (4+ Years)
This role supports clinical trial regulatory submissions and compliance activities across multiple phases of clinical development. ICON Hiring Clinical Trial Regulatory Scientist Jobs
Job Description
The Regulatory Scientist at ICON is responsible for managing and supporting regulatory submissions for clinical trials conducted in India. The role involves preparation, review, and submission of regulatory documents, coordination with cross-functional teams, and ensuring compliance with Indian and international regulatory requirements. ICON Hiring Clinical Trial Regulatory Scientist Jobs
This position is well suited for regulatory professionals seeking exposure to global clinical trials within a CRO environment. ICON Hiring Clinical Trial Regulatory Scientist Jobs
Key Responsibilities
- Support regulatory submissions for Phase I, II, and III clinical trials in India
- Prepare, review, and submit CT04, CT16, and related regulatory documents via the SUGAM portal
- Manage CTRI registrations, updates, and lifecycle maintenance
- Maintain and track regulatory documentation using electronic trial and document management systems
- Ensure compliance with ICH-GCP guidelines, CDSCO requirements, and NDCT 2019 regulations
- Collaborate with Clinical Operations, Data Integrity, and Regulatory Intelligence teams
- Monitor regulatory updates and changes in Indian clinical trial requirements
- Identify regulatory risks and contribute to mitigation strategies
- Maintain inspection-ready documentation and support audits and inspections
- Communicate regulatory timelines, milestones, and submission status to stakeholders
ICON Hiring Clinical Trial Regulatory Scientist Jobs
Skills / Qualifications
Educational Qualifications
Candidates must hold a bachelor’s or master’s degree in a scientific or healthcare-related discipline.
Accepted Education Backgrounds include:
- B.Pharmacy, M.Pharmacy, Pharm.D
- MSc Clinical Research, MSc Life Sciences, 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
- Experience with Indian clinical trial regulatory submissions
- CRO experience is preferred but not mandatory
Technical & Regulatory Skills
- Strong knowledge of ICH-GCP guidelines
- In-depth understanding of Indian clinical trial regulations, including NDCT 2019
- Practical experience with SUGAM portal submissions and CTRI registrations
- Familiarity with electronic regulatory and trial management systems
- Strong documentation, communication, and time management skills
ICON Hiring Clinical Trial Regulatory Scientist Jobs
Location & Salary
Job Locations
- Bengaluru
- Chennai
Salary
- Competitive and commensurate with experience
- As per industry standards for regulatory scientist roles
The role offers flexibility with office-based or home-based working, depending on project needs.
ICON Hiring Clinical Trial Regulatory Scientist Jobs
Why You Should Join ICON
- Work with a globally reputed CRO on innovative clinical development programs
- Gain exposure to end-to-end clinical trial regulatory activities
- Opportunity to work on multinational submissions and complex regulatory projects
- Strong learning environment with structured career progression
- Long-term growth opportunities in regulatory affairs and regulatory strategy
ICON Hiring Clinical Trial Regulatory Scientist Jobs
Frequently Asked Questions (FAQs)
Who can apply for the Regulatory Scientist role at ICON?
Life sciences and pharmacy graduates with 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 CDSCO and SUGAM portal experience is essential.
What regulatory systems will I work with?
You will work with electronic trial master file systems, clinical trial management systems, regulatory submission portals, and CTRI.
Is this a remote or office-based role?
The role may be office-based or home-based depending on project and operational requirements.
What is the career growth scope at ICON?
ICON offers global exposure and opportunities to grow into senior regulatory, regulatory strategy, and leadership roles.
Application Process
Interested and eligible candidates can apply directly through the official ICON careers portal.
Candidates are encouraged to apply even if they do not meet every requirement, as ICON values learning ability, transferable skills, and regulatory potential. ICON Hiring Clinical Trial Regulatory Scientist Jobs
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