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Regulatory Operations Principal Specialist | Pharmaceutical Regulatory Affairs & Project Leadership

Fortrea
Fortrea
5-9 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: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Operations Principal Specialist | Pharmaceutical Regulatory Affairs & Project Leadership

Job Location: Mumbai, India
Job Type: Full-Time
Department: Clinical / Regulatory Operations / Pharmaceutical Affairs
Work Mode: Office-Based / Hybrid / As per business requirements
Experience Required: 7–9 Years
Freshers Eligible: No
Industry: Pharmaceuticals / Clinical Research / Regulatory Affairs / Drug Development / Quality Assurance

Job Overview

We are hiring a Regulatory Operations Principal Specialist for a senior-level pharmaceutical regulatory affairs and project leadership role in Mumbai. This opportunity is ideal for experienced professionals with expertise in regulatory operations, pharmaceutical product lifecycle management, drug development, quality assurance, submission documentation, project management, and cross-functional team leadership.

The selected candidate will manage regulatory operations, client deliverables, compliance documentation, project execution, audit readiness, pharmaceutical analytical coordination, and team leadership across global healthcare and life sciences programs.

This role is highly suitable for professionals seeking career advancement in regulatory affairs leadership, pharmaceutical compliance, clinical operations, and strategic project management.

Key Responsibilities

  • Lead and oversee regulatory operations activities related to pharmaceutical product submissions, document preparation, revision, approval, and lifecycle management.
  • Manage regulatory deliverables for submissions to US, EU, Japan, and Rest of World (ROW) health authorities.
  • Provide project leadership, team management, and resource allocation support for client programs.
  • Conduct performance reviews, team mentoring, workload distribution, and people management activities.
  • Coordinate with CROs, contract laboratories, suppliers, internal stakeholders, and external clients to ensure timely project execution.
  • Provide analytical and technical support for development projects, comparative dissolution studies, and pharmaceutical research activities.
  • Design scientific experiments and monitor laboratory-related project execution where applicable.
  • Prepare technical documents including:
    • Test methods
    • Protocols
    • Regulatory reports
    • Scientific documentation
    • SOPs
    • Work instructions
  • Review and interpret pharmaceutical data sets, dissolution testing outputs, and investigation findings.
  • Troubleshoot issues related to analytical methods, instruments, and scientific processes.
  • Support multimedia dissolution testing, comparative dissolution studies, and in-vitro pharmaceutical analysis.
  • Ensure compliance with FDA, ICH, SUPAC, GxP, and international pharmaceutical regulatory guidelines.
  • Drive operational excellence, process improvements, productivity enhancement, and regulatory workflow optimization.
  • Prepare for and participate in internal audits, client audits, and regulatory inspections.
  • Work closely with quality assurance teams to improve compliance frameworks and training programs.
  • Lead client communication, delivery governance, and SLA-driven project execution.
  • Support SOP development, training delivery, documentation governance, and compliance oversight.
  • Identify risks, resolve operational challenges, and drive corrective actions proactively.

Required Qualifications

Candidates should meet one of the following educational requirements:

Option 1:

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

Option 2:

  • Advanced degree such as:
    • Master’s Degree
    • PhD
    • Equivalent advanced scientific qualification

Option 3:

  • Engineering / technical background 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 experience in regulatory affairs, pharmaceutical operations, analytical sciences, quality assurance, formulation science, packaging compliance, or drug development
  • At least 1+ year of project management and people management experience preferred
  • Experience in regulated pharmaceutical or life sciences environments required
  • Freshers are not eligible

Required Skills

  • Regulatory Affairs
  • Regulatory Operations
  • Pharmaceutical Compliance
  • Drug Development
  • Product Lifecycle Management
  • Submission Documentation
  • Quality Assurance
  • Project Management
  • Team Leadership
  • Client Management
  • Audit Readiness
  • SOP Development
  • Process Improvement
  • Scientific Documentation
  • Risk Management

Preferred Technical Skills

  • Microsoft Office Suite
  • Document Management Systems
  • MIS Reporting
  • Data Management Systems
  • Regulatory Publishing Tools
  • Pharmaceutical Documentation Platforms

Preferred Domain Knowledge

  • FDA Regulatory Guidelines
  • ICH-GCP Standards
  • SUPAC Compliance
  • Pharmaceutical Product Lifecycle
  • Dissolution Testing
  • In-vitro Analytical Testing
  • Formulation Science
  • Packaging Compliance
  • Global Regulatory Submission Processes

Leadership Competencies

  • Decision Making
  • Strategic Planning
  • Cross-functional Collaboration
  • Stakeholder Management
  • Problem Solving
  • Presentation Skills
  • Communication Leadership
  • Process Governance
  • Mentoring & Coaching
  • Execution Management