Regulatory Operations, Principal Specialist
Location: Mumbai
Category: Clinical
Job ID: 254596
Job Overview
Responsible for supporting laboratory compliance activities across global operations.
Summary of Responsibilities
(Not exhaustive; may include other duties as assigned)
Review and approve documents such as protocols and reports for:
Method qualification
Method validation
Method transfer
Investigations
Handle quality issues, corrective/preventive actions (CAPA), and change controls related to both clients and contract laboratories.
Collaborate with supported departments to maintain and improve quality culture, positively influencing Quality KPIs.
Actively participate in business and quality meetings, including CAPA boards, quality improvement programs, and team meetings (e.g., Connect meetings).
Qualifications (Minimum Required)
Bachelor’s degree in Pharmacy or related science (or equivalent).
Advanced degree (Master’s, PhD) preferred.
Fortrea may consider relevant and equivalent experience in lieu of formal education.
Language Skills:
Speaking: English (ILR level 3+ or higher)
Writing/Reading: English (ILR level 4 or higher)
Strong leadership, problem-solving, and interpersonal skills.
Experience (Minimum Required)
8–10 years in Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, Material Management, or overall drug development & manufacturing.
Minimum 1+ year of project management experience desirable.
Excellent command of written and spoken English.
Proficiency with Microsoft Office Suite, document management, and publishing tools.
Strong understanding of the pharmaceutical product life cycle.
Strong organizational and time management abilities.
Excellent interpersonal and analytical skills.
Customer-focused with good review and quality-control skills.
Experience with internal/external audits.
Knowledge of regulatory requirements, GxP and ICH guidelines.
Experience in:
Regulatory document formatting and publishing readiness
Regulatory Affairs/Operations/Publishing
Preferred Qualifications
Bachelor’s in Pharmacy or related science; advanced degree (Master’s/PhD) with 8–10 years relevant experience.
Knowledge of data management systems and pharmaceutical product life cycle.
Diploma or certification in Regulatory Affairs.
Demonstrated leadership, problem-solving, and interpersonal strengths.
Work Environment
Office-based role
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