PHARMAFull-time
Senior Global Regulatory Scientist
By Admin · Regulatory Affairs
BANGALORE (IN)HYBRIDPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE OVERVIEW
Senior Global Regulatory Scientist responsible for leading global clinical-trial regulatory activities, submission strategy, regulatory project teams, client deliverables, and compliance across pharmaceutical clinical trials in India.
ROLE DEFINITION & RESPONSIBILITIES
- •Ensure regulatory deliverables comply with applicable regulations, guidelines, policies, procedures, timelines, and budgets
- •Develop global clinical trial submission strategies with stakeholders and identify and mitigate regulatory risks
- •Lead assigned clinical trial Regulatory project teams
- •Serve as client point of contact for Regulatory deliverables
- •Prepare clinical trial Regulatory plans according to project specifications
- •Prepare, adapt, coordinate, collate, and ensure compliance of global core regulatory documents
- •Track submission and approval progress in CTMS, eTMF, and applicable systems
- •Coordinate submissions to regulatory agencies, central ethics committees, and country-level authorities
- •Coordinate clinical trial label review and approval
- •Manage Regulatory study budgets and identify out-of-scope activities
- •Maintain accurate country and regulatory intelligence
- •Perform quality control reviews and provide regulatory consulting support
- •Mentor junior Regulatory team members where applicable
Reporting Hierarchy: Leads assigned Regulatory project teams and serves as a client-facing regulatory contact; Works collaboratively with clinical, regulatory, client, and country-level stakeholders
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- BSc degree in a scientific field
- 3-6 years of relevant global regulatory experience in pharmaceutical clinical trials
- Good communication and client-facing skills
- Fluent English
- Ability to work with an adaptive and agile approach
PREFERRED QUALIFICATIONS
- •Experience coordinating global clinical trial submissions
- •Regulatory project-team leadership experience
- •Experience with CTMS and eTMF systems
- •Regulatory intelligence experience
- •Experience with regulatory consulting or client-facing pharmaceutical projects
REQUIRED VERIFIED SKILLS
Global Regulatory Affairs
clinical trial regulations
regulatory submissions
regulatory strategy
regulatory intelligence
CTMS
eTMF
clinical trials
pharmaceutical regulations
quality control
ethics committee submissions
regulatory agency submissions
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Bonus & Equity: Competitive base salary and performance related incentives
Benefits: Health and wellbeing programmes including applicable medical, dental and vision coverage; retirement and pension plans; life assurance and disability coverage; employee assistance and wellbeing resources; learning and development opportunities
The posting states that ICON offers a competitive base salary and performance-related incentives but does not disclose specific salary figures. No salary amount has been inferred.
ORGANIZATION CONTEXT & CULTURE
ICON is a global healthcare intelligence and clinical research organisation supporting the development of new medicines and treatments through clinical research and related services.
TEAM SIZE: 40,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
Culture: ICON emphasizes integrity, collaboration, agility, inclusion, professional development, and client-focused delivery.
EXPECTED CAREER ROADMAP
Can progress from Senior Global Regulatory Scientist into Regulatory Project Lead, Regulatory Manager, Associate Director, or broader global regulatory leadership and consulting roles depending on experience and internal opportunities.
APPLICATION ADVISORY
Emphasize 3-6 years of global pharmaceutical clinical-trial regulatory experience; highlight global submission strategy and regulatory-agency/ethics-committee coordination; demonstrate CTMS and eTMF experience; show client-facing communication and regulatory project leadership; mention regulatory intelligence, quality control, and budget-management experience where applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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