Job Title
Regulatory Operations Specialist II
Company
Fortrea
Location
Mumbai, India
Employment Type
Full-time
Job Overview
This role focuses on laboratory instrument lifecycle management and regulatory compliance in a cGMP (current Good Manufacturing Practices) environment. You will support quality systems, validation activities, and regulatory documentation related to pharmaceutical development and manufacturing.
Key Responsibilities
1. Laboratory Instrument Lifecycle Management
Manage full lifecycle of lab instruments:
Installation
Qualification
Maintenance
Ensure instruments and software meet regulatory and internal standards
Review instrument specifications against USP/EP standards
2. Validation & Quality Systems
Prepare and review:
SOPs (Standard Operating Procedures)
Validation Master Plans (VMP)
Protocols and cGMP documents
Support equipment qualification and validation activities
Maintain Preventive Maintenance schedules and asset records (e.g., eCMMS systems)
3. Compliance & Data Integrity
Conduct data integrity assessments of computerized systems
Handle non-conformance reports
Manage change control processes
Implement corrective and preventive actions (CAPA)
Support internal and external audits
4. Regulatory & Documentation Activities
Manage import/export licenses and related regulatory documentation
Handle NOCs (No Objection Certificates) and import certificates
Support regulatory compliance across product lifecycle stages
Maintain documentation trackers and quality metrics
5. Digital & Process Improvement
Support digital transformation in equipment lifecycle systems
Improve efficiency in regulatory and quality workflows
Identify process gaps and implement corrective solutions
6. Collaboration & Stakeholder Support
Coordinate with internal teams (ECLs, QA, regulatory teams)
Assist in onboarding and training junior staff
Communicate updates with clients and internal stakeholders
Support audits and inspections
Required Qualifications
One of the following:
Bachelor’s / Master’s / PhD in Pharmacy or related science
OR Engineering / B.Tech / Packaging / Polymer / Printing background
OR equivalent experience (4–7 years)
Required Experience
4–7 years in relevant fields such as:
Regulatory Affairs
Quality Assurance
Analytical science
Pharmaceutical manufacturing or development
Packaging/material science
Required Skills
Technical Skills
Understanding of:
cGMP (Good Manufacturing Practices)
GxP guidelines
ICH-GCP guidelines
Pharmaceutical lifecycle processes
Experience with:
Document management systems
Regulatory information systems
Microsoft Office tools
Core Competencies
Strong analytical and problem-solving skills
Attention to detail and quality focus
Good organizational and time management skills
Ability to work independently under deadlines
Process improvement mindset
Soft Skills
Strong communication skills
Leadership and mentoring ability
Proactive and ownership-driven approach
Team collaboration
Ability to handle multiple priorities
Preferred Skills
Regulatory Affairs certification or diploma
Experience with MIS / regulatory IT systems
Exposure to digital transformation in pharma systems
Strong root cause analysis capability
Work Environment
Office-based or remote flexible setup
May require travel based on business needs
Pharmaceutical regulatory and quality-focused environment
Role Summary (Simple Explanation)
This is a mid-level regulatory quality operations role focused on:
Managing lab instruments and validation systems
Ensuring pharmaceutical compliance (GMP/GxP)
Handling audits, documentation, and regulatory approvals
Supporting digital systems and process improvements
Working in pharma manufacturing and quality environments
Key Insight
This is not a fresher role
Requires 4–7 years experience
Strongly aligned with QA, validation, or regulatory operations in pharma industry
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