Senior Regulatory Affairs Specialist at Thermo Fisher Scientific's Clinical Research Group, based remotely in India. The role provides regulatory expertise and strategic guidance for clinical trial development across India and neighboring regions, ensuring compliance with CDSCO and ICH requirements while coordinating with internal and external stakeholders.
Monitor and communicate updates to Indian clinical trial regulations and CDSCO requirements to project teams
Coordinate with regional regulatory consultants in Pakistan, Nepal, and Sri Lanka on country-specific requirements
Prepare regulatory submissions and deliverables meeting local, regional, and ICH standards
Maintain regulatory documentation and tracking systems to ensure timely submission follow-up and compliance
Support preparation and documentation retrieval during regulatory inspections and audits
Knowledge of Indian clinical trial regulations, CDSCO notifications, and ICH guidelines
Experience maintaining regulatory trackers, submission logs, and compliance documentation
Understanding of clinical trial safety reporting requirements and adverse event procedures
Cross-functional collaboration skills with clinical operations and pharmacovigilance teams
Ability to identify regulatory gaps and escalate compliance risks proactively
Proficiency with standard office equipment and technology