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Regulatory Operations Specialist Ii | Pharmaceutical Regulatory Affairs & Compliance

Fortrea
Fortrea
4-7 years
preferred by company
Mumbai, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Operations Specialist II | Pharmaceutical Regulatory Affairs & Compliance

Job Location: Mumbai, India
Job Type: Full-Time
Department: Clinical / Regulatory Affairs / Pharmaceutical Operations
Work Mode: Office-Based / Remote / Hybrid (As per business requirements)
Travel Requirement: As per business needs
Experience Required: 4–7 Years
Freshers Eligible: No
Industry: Pharmaceuticals / Clinical Research / Regulatory Affairs / Quality Assurance / Drug Development

Job Overview

We are hiring a Regulatory Operations Specialist II for a pharmaceutical regulatory operations and compliance role in Mumbai. This opportunity is ideal for professionals with expertise in regulatory affairs, pharmaceutical compliance, laboratory instrument lifecycle management, quality systems, cGMP documentation, validation, and product lifecycle regulatory support.

The selected candidate will be responsible for supporting regulatory operations, equipment compliance, documentation governance, quality assurance activities, import/export regulatory coordination, and pharmaceutical product lifecycle management.

This role is highly suitable for experienced professionals seeking career growth in regulatory affairs, pharmaceutical operations, validation, compliance management, and healthcare quality systems.

Key Responsibilities

  • Manage the complete lifecycle of laboratory instruments, including installation, qualification, calibration, maintenance, and compliance oversight.
  • Oversee qualification of laboratory equipment, software systems, and validation processes in regulated pharmaceutical environments.
  • Prepare, review, and maintain SOPs, validation protocols, validation master plans (VMP), maintenance documentation, and cGMP-controlled records.
  • Handle nonconformance investigations, deviation management, change controls, CAPA implementation, and compliance documentation.
  • Support digital transformation initiatives within equipment lifecycle and regulatory operational workflows.
  • Maintain documentation related to:
    • Preventive Maintenance Schedules
    • eCMMS Assets
    • Maintenance Master Plans (MMP)
    • Validation Master Plans (VMP)
  • Conduct data integrity assessments for computerized systems to ensure regulatory compliance.
  • Evaluate instrument specifications against USP/EP pharmaceutical compliance standards.
  • Support implementation of systems aligned with regulatory and quality requirements.
  • Manage laboratory documentation processes including notebooks, SOP review schedules, and work instructions.
  • Support internal audits, client audits, and regulatory inspections.
  • Coordinate equipment lifecycle management support activities with internal operational teams.
  • Manage import/export licenses, dual-use NOCs, import certificates, regulatory submissions, license tracking, reconciliation, and compliance records.
  • Maintain internal and client regulatory trackers, quality metrics, and compliance reporting documentation.
  • Support onboarding, training, mentoring, and process knowledge transfer for junior staff.
  • Maintain training documentation in accordance with internal and client compliance standards.
  • Identify operational risks, escalate critical issues, and contribute to continuous process improvement initiatives.

Required Qualifications

Candidates should meet one of the following educational criteria:

Option 1:

  • Bachelor’s degree in:
    • Pharmacy
    • Pharmaceutical Sciences
    • Life Sciences
    • Related scientific discipline

Option 2:

  • Advanced qualification such as:
    • Master’s Degree
    • PhD
    • Equivalent relevant advanced academic credentials

Option 3:

  • Engineering / Technical educational background in:
    • B.Tech
    • Packaging Engineering
    • Polymer Science
    • Printing Technology
    • Packaging Diploma / Certification

Equivalent relevant professional experience may be considered.

Experience Requirements

  • Minimum 4–7 years of relevant experience in regulatory affairs, pharmaceutical quality assurance, analytical sciences, packaging compliance, manufacturing operations, or pharmaceutical product lifecycle management
  • Experience in regulated pharmaceutical or healthcare environments required
  • Freshers are not eligible