Senior Regulatory Affairs Specialist

Thermo Fisher Scientific

. Serve as a senior specialist contact within India at CRG, Thermo Fisher Scientific .

Posted 11/12/2026full-timeRemote • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory affairs, particularly within Indian clinical trial regulations and compliance. Capable of providing strategic regulatory intelligence and maintaining thorough regulatory documentation while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs ExpertiseIndian Clinical Trial RegulationsCDSCO Electronic Submission SystemsRegulatory Documentation ManagementCross-Functional Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SolutionsClinical Trial ApplicationsSAE ReportingRegulatory SubmissionsRegulatory ComplianceRegulatory TrackersSubmission LogsApproval RecordsRegulatory AmendmentsRegulatory Inspection Requirements

Soft Skills

Strategic CommunicationProblem-SolvingAdaptabilityTime ManagementCollaboration

Tools & Technologies

SUGAM PortalStandard Office Equipment

Industry Keywords

CDSCO NotificationsClinical OperationsPharmacovigilanceDrug SafetySite ActivationRegulatory IntelligenceCompliance RisksRegulatory GapsMiddle East Regulatory ComplianceRegional Regulatory Consultants

About the role

Key responsibilities & impact

Serve as a senior specialist contact within India at CRG, Thermo Fisher Scientific
Provide innovative regulatory solutions and regulatory expertise
Interact with clients to provide strategic regulatory intelligence and guidance from preclinical development through registration and product optimization
Ensure compliance with regulatory bodies in the Middle East
Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements
Act as liaison with internal and external clients in delivering and marketing specialized regulatory services
Monitor Indian clinical trial regulations, CDSCO notifications, guidelines, and regulatory requirements
Coordinate with consultants in Pakistan, Nepal, and Sri Lanka on regulatory updates and country-specific requirements
Maintain regulatory trackers, submission logs, approval records, and regulatory documentation
Coordinate with cross-functional Clinical Operations, Pharmacovigilance/Drug Safety, and Site Activation teams
Support SAE reporting, regulatory submissions, notifications, follow-up activities, inspections, and audits
Identify and escalate regulatory gaps, delays, and compliance risks

Requirements

What you’ll need

Senior specialist regulatory affairs experience and expertise
Ability to monitor Indian clinical trial regulations, CDSCO notifications, guidelines, and applicable regulatory requirements
Ability to coordinate with local regulatory consultants for Pakistan, Nepal, and Sri Lanka
Familiarity with CDSCO electronic submission systems, including the SUGAM portal
Basic understanding of clinical trial applications, import licence requirements, regulatory amendments, and reporting obligations
Ability to maintain regulatory trackers, submission logs, approval records, and regulatory documentation
Ability to collaborate with Clinical Operations, Pharmacovigilance/Drug Safety, Site Activation, and other cross-functional teams
Basic understanding of clinical trial safety reporting requirements in India, including SAE reporting and applicable regulatory timelines
Basic understanding of regulatory inspection and audit requirements
Ability to identify regulatory gaps, submission delays, and compliance risks and escalate concerns
Willingness to continuously develop regulatory knowledge and adapt to evolving requirements
Ability to work effectively with regional and global teams across different time zones
Ability to communicate and understand information with diverse groups
Ability to work upright and stationary for typical working hours
Ability to use and learn standard office equipment and technology
Ability to work under pressure while prioritizing and handling multiple projects
May require travel

Benefits

Comp & perks

Competitive remuneration
Annual incentive plan bonus
Healthcare
Employee benefits
Career and development prospects
Flexible working hours when required to support critical deliverables and meetings