🧾 Regulatory Operations, Principal Specialist
Location: Mumbai
Category: Clinical
Job ID: 254596
Company: Fortrea
🎯 Job Overview
The Regulatory Operations, Principal Specialist is responsible for supporting laboratory compliance activities, ensuring adherence to regulatory guidelines, quality standards, and GxP requirements. This role involves document review, quality issue management, CAPA handling, and contributing to continuous improvement initiatives across regulatory and analytical domains.
🧠 Key Responsibilities
🔹 Document Review & Approval
Review and approve regulatory and technical documents including:
Protocols and reports for method qualification, method validation, and method transfer
Methods documentation and investigation reports
Ensure accuracy, compliance, and publishing readiness of all documentation.
🔹 Quality Issue Management
Handle Quality Issues, Corrective and Preventive Actions (CAPA), and Change Controls related to both clients and contract laboratories.
Drive effective resolution and documentation of quality-related deviations.
🔹 Compliance & Continuous Improvement
Collaborate with supported departments to strengthen the quality culture.
Positively influence Quality KPIs through proactive quality initiatives.
Participate in internal quality improvement activities such as:
CAPA Board Meetings
Quality Improvement Programs
Connect Team Meetings
🔹 Leadership & Stakeholder Engagement
Engage with cross-functional teams, internal auditors, and external auditors to ensure compliance.
Demonstrate leadership in problem-solving, project execution, and communication with stakeholders.
🎓 Qualifications
📘 Education (Minimum Required)
Bachelor’s Degree in Pharmacy or related science discipline, OR
Advanced degree (e.g., Master’s, PhD) preferred.
🔹 Fortrea may consider relevant and equivalent experience in lieu of formal educational requirements.
💬 Language Proficiency
Speaking: English at ILR Level 3+ or higher
Reading/Writing: English at ILR Level 4+ or higher
🧩 Core Competencies
Leadership & Problem-Solving Skills
Strong Interpersonal & Communication Skills
High Attention to Detail and Quality Focus
💼 Experience (Minimum Required)
8–10 years of experience in one or more of the following:
Regulatory Affairs (RA)
Quality Assurance (QA)
Analytical Science
Formulation Science
Material Management
Drug Development and Manufacturing Process
1+ year experience in Project Management (preferred)
📚 Technical Skills
Proficiency in Microsoft Office Suite, Document Management Systems, and Regulatory Publishing Tools
Strong understanding of:
Pharmaceutical Product Life Cycle
Regulatory Document Formatting and Publishing Readiness
GxP, ICH Guidelines, and Regulatory Requirements
Familiarity with Scientific or Clinical Research processes (desirable)
Audit readiness and experience in Internal/External Audits
🌟 Preferred Qualifications
Advanced Degree (PhD/Master’s) with 8–10 years of relevant experience
Diploma or Certification in Regulatory Affairs
Knowledge of Data Management Systems and Pharmaceutical Life Cycle
Demonstrated Leadership, Analytical Thinking, and Customer Focus
Strong Organizational and Time Management abilities
🧭 Key Strengths
Strategic understanding of drug development lifecycle
Excellent review, analytical, and decision-making capabilities
Ability to handle complex regulatory submissions and ensure compliance
Proven track record in cross-functional collaboration
🏢 Work Environment
Office-based role with potential collaboration across global teams
⚖️ Equal Employment Opportunity (EEO)
Fortrea is an equal opportunity employer. We are committed to providing reasonable accommodations to qualified individuals with disabilities during all phases of employment.
🔗 Learn more: EEO & Accommodations Information
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