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Regulatory Operations Specialist Iii

Fortrea
Fortrea
7-9 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 III | Pharmaceutical Regulatory Affairs & Analytical Operations

Job Location: Mumbai, India
Job Type: Full-Time
Department: Clinical / Regulatory Operations / Pharmaceutical Sciences
Work Mode: Office-Based / Remote / Hybrid (As per business requirements)
Travel Requirement: 5–10% Regional or Global Travel (Including Overnight Travel as Required)
Experience Required: 7–9 Years
Freshers Eligible: No
Industry: Pharmaceuticals / Clinical Research / Regulatory Affairs / Analytical Sciences / Drug Development

Job Overview

We are hiring a Regulatory Operations Specialist III for a senior pharmaceutical regulatory and analytical operations role in Mumbai. This opportunity is ideal for experienced professionals with expertise in comparative dissolution studies, pharmaceutical analytical testing, regulatory compliance, GMP operations, formulation science, quality assurance, and drug development lifecycle management.

The selected candidate will support complex pharmaceutical development projects, analytical investigations, regulatory documentation, CRO coordination, quality compliance, and client delivery excellence across global healthcare programs.

This role is ideal for professionals seeking advanced career growth in regulatory operations, pharmaceutical sciences, analytical development, and quality-driven drug development operations.

Key Responsibilities

  • Provide analytical and regulatory support for developmental pharmaceutical projects and comparative dissolution studies.
  • Coordinate with CROs, contract laboratories, suppliers, customers, and internal teams to ensure project delivery within defined timelines.
  • Design scientific experiments and actively monitor analytical laboratory workflows.
  • Prepare and maintain:
    • Scientific protocols
    • Test methods
    • Technical reports
    • Analytical documentation
    • SOPs
    • Work instructions
  • Maintain accurate documentation, raw data records, and scientific compliance records.
  • Analyze dissolution datasets and interpret analytical findings to support development decisions.
  • Troubleshoot issues related to analytical instruments, laboratory processes, and testing methodologies.
  • Perform activities in compliance with GMP standards, pharmaceutical safety protocols, and quality regulations.
  • Conduct:
    • Comparative dissolution studies
    • Multimedia dissolution testing
    • In-vitro analytical investigations
  • Apply regulatory understanding related to:
    • FDA SUPAC guidelines
    • ICH standards
    • Global regulatory expectations including emerging markets
  • Support formulation-related analytical activities for oral solid dosage pharmaceutical products.
  • Drive process improvement initiatives to improve productivity, quality, and operational efficiency.
  • Collaborate with quality assurance teams to develop training materials, SOPs, and compliance processes.
  • Support mentoring and capability development for project teams.
  • Participate in client audits, regulatory inspections, and internal compliance reviews.
  • Contribute to project governance, cross-functional meetings, stakeholder communication, and issue resolution.
  • Ensure SLA-driven client delivery and customer satisfaction standards are consistently achieved.

Required Qualifications

Candidates should meet one of the following educational pathways:

Option 1:

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

Option 2:

  • Advanced academic qualifications such as:
    • Master’s Degree
    • PhD
    • Equivalent scientific qualifications

Option 3:

  • Technical or engineering qualifications in:
    • B.Tech
    • Packaging Engineering
    • Polymer Science
    • Printing Technology
    • Packaging Diploma / Certification

Equivalent relevant professional experience may be considered.

Experience Requirements

  • Minimum 7–9 years of relevant experience in regulatory affairs, analytical sciences, quality assurance, formulation science, pharmaceutical packaging, material management, or drug development
  • Minimum 1+ year of project management experience preferred
  • Strong exposure to GMP-regulated pharmaceutical environments
  • Experience in regulatory documentation, analytical investigations, and compliance operations preferred
  • Freshers are not eligible