Job Description – Regulatory Operations, Principal Specialist
Location: Mumbai, India
Category: Clinical
Job ID: 254596
Work Environment: Office-based
Job Type: Full-time
Job Overview
The Regulatory Operations, Principal Specialist is responsible for providing support in laboratory compliance activities, ensuring adherence to regulatory standards, quality culture, and operational excellence. This role involves reviewing and approving critical documents, managing quality issues, and supporting cross-functional collaboration to achieve compliance goals.
Key Responsibilities
Document Review & Approval:
Review and approve protocols and reports for method qualification, validation, and transfer.
Evaluate methods, investigations, and related regulatory documents.
Quality & Compliance:
Handle Quality Issues, Corrective/Preventive Actions (CAPA), and Change Controls related to clients and contract laboratories.
Support compliance with regulatory requirements, GxP, and ICH guidelines.
Ensure regulatory document formatting and publishing readiness.
Collaboration & Improvement:
Work with departments to strengthen and improve quality culture and positively influence Quality KPIs.
Actively participate in business meetings including CAPA board reviews, Quality Improvement Programs, and team connect meetings.
Qualifications
Minimum Required
Education:
Bachelor’s degree in Pharmacy or related science.
Advanced degree (Master’s/PhD) preferred.
Equivalent relevant experience may be considered in lieu of educational requirements.
Language Proficiency:
English Speaking: ILR Level 3+
English Writing/Reading: ILR Level 4+
Skills & Competencies:
Leadership, problem-solving, and interpersonal skills.
Strong organizational and time management abilities.
Technical proficiency with Microsoft Office, Document Management, and publishing tools.
Strong analytical and review capabilities with customer focus.
Ability to manage audit situations (internal & external) effectively.
Experience:
8–10 years in Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, Material Management, or drug development/manufacturing processes.
1+ year of project management experience (desirable).
Knowledge of pharmaceutical product life cycle and regulatory publishing.
Prior exposure to scientific or clinical research (desirable).
Preferred Qualifications
Advanced degree (Master’s/PhD) with 8–10 years of relevant industry experience.
Diploma or certification in Regulatory Affairs.
Knowledge of data management systems and regulatory publishing.
Strong leadership, interpersonal, and problem-solving skills.
Work Environment
Primarily office-based role with cross-functional collaboration and audit participation.
Equal Employment Opportunity (EEO)
Fortrea is committed to equal opportunity employment and providing reasonable accommodations as required.
✨ This position is best suited for professionals with deep regulatory expertise and experience in compliance operations, who are ready to drive quality improvements and support global regulatory activities.
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