Job Title: Principal Regulatory Affairs Assistant
Location: Bangalore, Karnataka, India
Employment Type: Full-Time | Onsite
Category: Clinical Research / Regulatory Affairs
Job ID: R-01333869
Experience Required: Minimum 1+ year in Regulatory Affairs or Clinical Research Support
Our Clinical Research Services team plays a critical role in advancing therapies from development to market. As part of a leading global Contract Research Organization (CRO), the team supports regulatory and clinical programs worldwide with strong scientific, regulatory, and operational expertise. Through our integrated clinical research portfolio, we contribute to developing treatments for some of the world’s most complex health challenges.
We are seeking a Principal Regulatory Affairs Assistant to support regulatory documentation, submissions, and compliance activities in alignment with EU Clinical Trial Regulation (EUCTR) guidelines. This role is ideal for professionals looking to build or strengthen their career in regulatory affairs within a global CRO environment. The position involves close coordination with internal teams and external clients to ensure timely, compliant regulatory deliverables.
Support preparation, review, and submission of regulatory documentation under EUCTR guidelines
Coordinate and manage client deliverables to ensure regulatory compliance and adherence to timelines
Track project milestones and provide status updates to internal stakeholders and clients
Maintain up-to-date knowledge of internal SOPs, client SOPs, directives, and current global regulatory guidelines
Evaluate client requirements in relation to project timelines, quality standards, and delivery expectations
Collaborate with cross-functional teams to resolve issues and mitigate risks impacting project delivery
Provide project-specific regulatory support, documentation, and reporting to management and clients
Assist in the preparation of bids, proposals, contract modifications, and bid defense documentation
Generate, track, and analyze data related to proposals and regulatory project support
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline
Minimum 1+ year of relevant experience in regulatory affairs, clinical research coordination, or CRO operations
Understanding of clinical trial regulations, especially EUCTR, is preferred
Strong organizational, documentation, and coordination skills
Ability to manage multiple tasks in a deadline-driven, regulated environment
Effective written and verbal communication skills in English
Opportunity to work with a globally recognized CRO
Exposure to international regulatory frameworks and clinical research operations
Collaborative, professional, and growth-oriented work environment
Strong foundation for long-term career progression in Regulatory Affairs and Clinical Research
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