ICON
Company: ICON plc
Job Title: Senior Global Regulatory Scientist
Location: Bengaluru, Karnataka, India
Work Mode: Office-Based
Department: Global Regulatory Affairs / Clinical Trial Regulatory
Experience: 3–6 Years
Qualification: B.Sc. in a Scientific Field
Industry: Clinical Research, CRO, Pharmaceutical
Job Type: Full-Time
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organisation committed to accelerating the development of new medicines and treatments for patients worldwide. The company focuses on clinical research, regulatory support, and healthcare innovation, fostering a workplace culture built around integrity, collaboration, agility, and inclusion.
ICON is inviting applications for the position of Senior Global Regulatory Scientist at its Bengaluru, Karnataka, India, office.
Job Overview
The Senior Global Regulatory Scientist will oversee clinical trial regulatory activities, coordinate global and country-level regulatory submissions, develop submission strategies, and ensure compliance with applicable regulations and guidelines. The role involves collaboration with clients, internal project teams, regulatory agencies, and ethics committees.
Candidates should have relevant global regulatory experience in pharmaceutical clinical trials, strong communication skills, and the ability to independently manage regulatory deliverables.
Key Responsibilities
- Develop global clinical trial regulatory submission strategies in collaboration with project stakeholders.
- Lead regulatory activities for assigned clinical trial projects.
- Prepare, review, coordinate, and finalise regulatory plans and core documentation.
- Coordinate submissions to regulatory agencies, central ethics committees, and country-level authorities.
- Monitor submission timelines and approval progress using CTMS, eTMF, and other relevant systems.
- Perform quality control reviews of clinical trial regulatory deliverables.
- Ensure compliance with applicable regulations, ICH guidelines, Good Clinical Practice (GCP), and company procedures.
- Serve as a regulatory point of contact for clients and internal project teams.
- Coordinate clinical trial labelling review and approval activities.
- Manage regulatory project budgets, timelines, and contracted scope.
- Identify regulatory risks and support the development of mitigation strategies.
- Support project audits, corrective and preventive actions (CAPAs), and proposal or bid defence activities.
- Maintain accurate and up-to-date global, regional, and country-specific regulatory intelligence.
- Mentor junior team members and contribute to process improvement initiatives when required.
Eligibility Criteria
Candidates applying for this position should meet the following requirements:
- Educational Qualification: B.Sc. degree in a scientific field.
- Experience: 3–6 years of relevant global regulatory experience in pharmaceutical clinical trials.
- Strong understanding of clinical trial regulatory submissions and applicable regulations.
- Knowledge of ICH, GCP, regulatory procedures, and relevant documentation requirements.
- Excellent written and verbal English communication skills.
- Good client-facing, organisational, and stakeholder management skills.
- Ability to work independently, manage multiple deliverables, and meet project deadlines.
- Willingness to travel less than 10% of the time.
What ICON Offers
ICON provides a professional environment focused on employee development, diversity, and high performance. The organisation offers competitive compensation and benefits designed to support employee well-being and work-life balance.
How to Apply
Interested and eligible candidates should visit the official ICON Careers website to review the complete job description and submit their application.
Official Careers Website: https://careers.iconplc.com/
Search for Senior Global Regulatory Scientist and select the Bengaluru, India, location to find the relevant opening.
To apply for this job please visit careers.iconplc.com.

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