Job Title: Regulatory Operations, Principal Specialist
📍 Location: Mumbai
🏢 Category: Clinical
🆔 Job ID: 254596
Job Overview
The Regulatory Operations, Principal Specialist is responsible for supporting lab compliance activities, managing regulatory documentation, and ensuring adherence to quality standards. This role contributes to maintaining and improving the quality culture and regulatory compliance within the organization.
Key Responsibilities
📄 Regulatory Documentation & Review
Review and approve documents such as:
Protocols and reports for method qualification, validation, and transfer
Investigation reports and analytical methods
Ensure regulatory documents are formatted, published, and ready for submission.
⚙️ Quality & Compliance
Handle quality issues, Corrective/Preventive Actions (CAPA), and Change Controls for client and contract laboratories.
Maintain and continuously improve the quality culture to positively influence Quality KPIs.
Participate in meetings such as:
CAPA board
Quality Improvement Program
Team connect meetings
🧪 Cross-Functional Collaboration
Work with supported departments to provide regulatory support and ensure GxP compliance.
Assist during internal and external audits, maintaining readiness for review.
Minimum Qualifications
🎓 Education:
Bachelor’s degree in Pharmacy or related science (or equivalent)
Advanced degree (e.g., PhD or Master’s) preferred
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
🗣️ Language Skills:
English speaking: ILR level 3+
English reading/writing: ILR level 4+
💡 Skills & Competencies:
Leadership and project management capabilities
Problem-solving and analytical skills
Interpersonal and team collaboration skills
Strong organizational and time management abilities
Customer focus and attention to quality
Technical proficiency with Microsoft Office and document management tools
Experience Requirements
8–10 years experience in:
Regulatory Affairs
Quality Assurance
Analytical Science / Formulation Science / Material Management
Overall drug development and manufacturing processes
1+ year of project management experience (desirable)
Knowledge of pharmaceutical product life cycle and regulatory requirements
Experience in regulatory document publishing and ensuring compliance with GxP and ICH guidelines
Scientific or clinical research experience (desirable)
Preferred Qualifications
Diploma or certification in Regulatory Affairs
Advanced degree (PhD / Master’s) with relevant experience
Strong understanding of data management systems in regulatory operations
Work Environment
🏢 Environment: Office-based
🖥️ Tools & Technology: Microsoft Office Suite, document management, and publishing tools
Equal Opportunity & Accommodation
Fortrea is an Equal Opportunity Employer, committed to providing reasonable accommodations to qualified individuals.
📎 Learn more about EEO & Accommodations [here].
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