Job Title: Regulatory Operations, Principal Specialist
Location: Mumbai, India
Category: Clinical
Job ID: 254596
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing clinical development and technology solutions to pharmaceutical, biotechnology, and medical device customers worldwide. With operations in approximately 100 countries and expertise spanning more than 20 therapeutic areas, Fortrea is committed to accelerating drug and device development for partners and patients globally.
Our culture, Fortrea FOUR, is centered on Forward Together, Own It, Uphold Integrity, and Respect People. Join our team for a collaborative, growth-focused work environment.
Learn more at: www.fortrea.com
Job Overview
The Principal Specialist in Regulatory Operations will provide critical support for laboratory compliance activities. This role includes document review and approval, managing quality issues, and driving continuous quality improvement efforts within supported departments.
Key Responsibilities
Review and approve documents related to method qualification, validation, transfer, and investigations (including protocols and reports).
Manage quality issues such as Corrective/Preventive Actions (CAPA) and Change Controls related to the client and contract laboratories.
Collaborate with supported departments to maintain and improve quality culture, influencing Quality Key Performance Indicators (KPIs).
Actively participate in quality-related meetings including CAPA boards, quality improvement programs, and team connect meetings.
Qualifications
Minimum Education
Bachelor’s degree in Pharmacy or related science field (or equivalent).
Advanced degree (PhD or Masters) preferred but not mandatory.
Relevant and equivalent experience may be considered in lieu of formal education.
Language Proficiency
Speaking: English at ILR Level 3+ or higher.
Writing/Reading: English at ILR Level 4 or higher.
Experience
8 to 10 years of experience in one or more of the following areas: Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, Material Management, drug development, and manufacturing processes.
Minimum 1+ year of project management experience is desirable.
Scientific or clinical research experience is advantageous.
Experience in regulatory document formatting, publishing readiness, regulatory affairs operations, and compliance.
Proven ability to manage internal and external audits.
Strong understanding of regulatory requirements, GxP, and ICH guidelines.
Skills and Competencies
Leadership and problem-solving capabilities.
Excellent interpersonal and communication skills.
Strong organizational and time management skills.
Good analytical abilities and customer focus.
Proficiency with Microsoft Office suite, document management systems, and publishing tools.
Good review skills with high concern for quality.
Knowledge of pharmaceutical product life cycle and data management systems.
Preferred Qualifications
Diploma or certification in Regulatory Affairs.
Advanced degree (PhD or Masters) in Pharmacy or related sciences with relevant experience.
Work Environment
Office-based role in Mumbai.
Equal Employment Opportunity & Accessibility
Fortrea is an Equal Opportunity Employer and provides reasonable accommodations to individuals with disabilities throughout the hiring process.
How to Apply
For tailored job alerts and to share this opportunity, please visit Fortrea’s careers page or sign up for email notifications.
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