Senior Global Regulatory Scientist
Job Type: Full-time
Work Model: Office or Home (Hybrid/Flexible)
Locations: Bangalore (India), Trivandrum (India), Chennai (India), Kuala Lumpur (Malaysia), Seoul (Korea)
Organization: ICON plc
Job ID: JR142445
About the Organization
ICON plc is a global healthcare intelligence and clinical research organization specializing in clinical development, regulatory support, and data-driven healthcare solutions. The organization partners with pharmaceutical and biotech companies to ensure efficient and compliant drug development.
Role Overview
The Senior Global Regulatory Scientist acts as a Global Regulatory Partner (GRP) responsible for managing regulatory submissions, ethics committee approvals, and coordination of global clinical trial regulatory activities.
The role ensures that all submissions comply with global regulatory standards, contractual timelines, and scientific requirements.
Key Responsibilities
1. Regulatory Strategy & Submission Management
Develop global clinical trial regulatory submission strategies
Prepare and implement regulatory plans aligned with study requirements
Coordinate submissions to:
Regulatory Authorities (RA)
Central Independent Ethics Committees (IEC)
Country-level regulatory bodies
2. Project Leadership
Lead regulatory project teams for assigned clinical trials
Act as primary regulatory point of contact for clients
Ensure alignment between regulatory deliverables and project timelines
3. Document Preparation & Compliance
Create, adapt, and coordinate global regulatory core documents
Ensure accuracy and completeness in regulatory submissions
Perform quality control (QC) reviews of regulatory deliverables
Maintain compliance with global regulatory guidelines and standards
4. Tracking & Reporting
Track submission progress using systems such as:
CTMS (Clinical Trial Management System)
eTMF (electronic Trial Master File)
Ensure timely updates and accurate documentation reporting
5. Labeling & Budget Management
Coordinate clinical trial labeling review and approvals
Manage regulatory study budgets and identify out-of-scope activities
6. Stakeholder Collaboration
Collaborate with internal and external stakeholders across global teams
Provide regulatory consulting support when needed
May support business development initiatives
7. Mentorship & Leadership
Guide and mentor junior regulatory team members
Support knowledge sharing across regulatory functions
Required Qualifications
Education
Bachelor’s degree in a scientific or healthcare-related field
Experience
Minimum 3+ years in regulatory affairs within clinical research
Experience in clinical trial submissions is essential
Technical Knowledge
Strong understanding of:
Global regulatory frameworks
Clinical trial regulations (ICH-GCP, country-specific guidelines)
Ethics committee and regulatory submission processes
Skills
Strong project management and coordination abilities
Excellent attention to detail
Ability to manage multiple global submissions simultaneously
Strong written and verbal communication skills in English
Soft Skills
Ability to work independently and in cross-functional global teams
Strong stakeholder management skills
Ability to perform under tight timelines and regulatory pressure
Core Competencies
Regulatory affairs strategy
Clinical trial submission management
Global compliance coordination
Cross-functional leadership
Document quality assurance
Equal Opportunity Statement
ICON plc promotes diversity, inclusion, and equal opportunity employment. All applicants are considered without discrimination based on race, gender, disability, or other protected characteristics.
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Remote, India | Siliguri |Illinois :
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