Looking to build a career in Regulatory Affairs and Clinical Data Management? A full-time Associate GRAAS Operations role is now open in Hyderabad, India, offering hands-on exposure to global regulatory submissions, document management systems, and GMP-compliant workflows. This opportunity is ideal for freshers or early-career professionals aiming to enter Global Submission & Information Management (GSIM).
๐ Job Overview
- Role: Associate โ GRAAS Operations (GSIM Regulatory Data Management)
- Location: Hyderabad, India (On-site)
- Department: Global Regulatory Affairs Execution
- Employment Type: Full-Time
- Job ID: R-242351
- Industry: Regulatory Affairs / Clinical Research
This role focuses on ensuring accurate regulatory data flow, submission tracking, and compliance with global health authorities.
๐ Key Responsibilities
As an Associate GRAAS Operations professional, your core responsibilities will include:
- Monitoring regulatory data quality and submission timelines
- Updating Regulatory Submissions & Document Information Management Systems (RSDIMS)
- Managing clinical trial submissions and marketing applications
- Maintaining regulatory archives (on-site and off-site documentation)
- Coordinating between Regulatory Affairs, CMC teams, and publishing teams
- Handling Protocol Amendment New Investigator (PANI) submissions
- Managing FDA Form 1572 documentation
- Ensuring compliance with SOPs, GMP systems, and regulatory guidelines
- Supporting cross-functional teams and external CRO partners
- Compiling and analyzing regulatory metrics and analytics
๐ Qualifications & Eligibility
Basic Requirements:
- Bachelorโs degree Or Masters Degree
Preferred:
- Experience in Regulatory Affairs Operations
- Familiarity with:
- Global Clinical Trial Applications
- Marketing Authorization processes
- Regulatory guidelines (FDA, EMA, etc.)
- Basic knowledge of Veeva Vault system
- Strong communication, attention to detail, and time management skills
๐ง Required Skills
- Regulatory data management & tracking
- Knowledge of GMP-compliant systems
- Critical thinking and problem-solving
- Collaboration with global teams
- Ability to manage multiple regulatory workflows simultaneously
๐ผ Salary & Benefits
- Estimated Salary: โน4.5 LPA โ โน8 LPA (based on industry standards for regulatory operations roles in India)
- Exposure to global regulatory submissions
- Opportunity to work with cross-functional international teams
- Career growth in Regulatory Affairs, Clinical Operations, and Data Management
- Skill development in Veeva Vault, RSDIMS, and GMP systems
๐ Why This Role Matters
The Associate GRAAS Operations role is critical in ensuring seamless communication between regulatory bodies, sponsors, and internal teams. It directly impacts clinical trial approvals, compliance, and product lifecycle management, making it a high-value entry point into global regulatory careers.
๐ฉ How to Apply
