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Fortrea Hiring Pharmacovigilance Workflow Analyst & Regulatory Operations

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Fortrea

BS/BA, B.Pharm, M.Pharm, Pharmaceutics, Life Sciences, PhD, Packaging, Polymer, Printing, Engineering, B.Tech, Related Science Degree, Packaging Diploma/Certification

Mumbai / Pune

2โ€“9 years experience in Pharmacovigilance, Regulatory Affairs, Analytical Science, Quality Assurance, Workflow Management, Packaging, Formulation Science, Drug Development, CRO Operations, Data Management, or Pharmaceutical Industry roles.

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Fortrea Careers has announced multiple openings for experienced professionals in Pharmacovigilance, Regulatory Operations, Analytical Science, and Workflow Management across Mumbai and Pune. The company is actively recruiting candidates from pharmacy, life sciences, regulatory affairs, formulation science, and packaging backgrounds.

The latest Fortrea jobs in India include openings for Workflow Analyst, Regulatory Operations Principal Specialist, Regulatory Operations Specialist II, and Regulatory Operations Specialist III. Candidates with experience in pharmacovigilance operations, regulatory affairs, dissolution studies, analytical science, and project management are encouraged to apply.

These Fortrea regulatory affairs jobs offer opportunities to work with global pharmaceutical clients, CRO operations, regulatory documentation, dissolution testing, safety databases, and compliance activities aligned with ICH-GCP and GMP standards.

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1. Workflow Analyst โ€“ Fortrea

  • Location: Mumbai / Pune
  • Job Type: Full-Time
  • Work Mode: Remote
  • Experience Required: 2โ€“4 Years
  • Qualification: BS/BA, B.Pharm, M.Pharm, Life Sciences or related field
  • Application Deadline: May 10, 2026

Key Responsibilities

  • Manage pharmacovigilance workflow and case allocation
  • Track ICSRs and regulatory timelines
  • Maintain master tracking sheets and productivity reports
  • Reconcile TAT and workflow metrics
  • Generate quality, productivity, and dashboard reports
  • Support safety database operations and reporting
  • Prepare presentations and analytical reports

Required Skills

  • Understanding of pharmacovigilance and safety databases
  • Knowledge of ICSR case processing and SLA timelines
  • Strong Excel and reporting skills
  • Familiarity with Argus safety database preferred
  • Good analytical and workflow management skills

Preferred Candidates

Candidates with experience in:

  • Pharmacovigilance operations
  • Data management
  • Records management
  • Workflow coordination
  • Reporting and metrics tracking

2. Regulatory Operations Principal Specialist โ€“ Fortrea

  • Location: Mumbai
  • Job Type: Full-Time
  • Experience Required: 7โ€“9 Years
  • Qualification: B.Pharm, M.Pharm, PhD, Packaging, Polymer, Printing or related science degree
  • Application Deadline: May 15, 2026

Key Responsibilities

  • Lead regulatory operations and analytical science projects
  • Coordinate comparative dissolution and multimedia dissolution studies
  • Manage CRO interactions and project timelines
  • Review protocols, reports, specifications, and regulatory documents
  • Support audits, SOP development, and compliance activities
  • Mentor and manage project teams
  • Handle regulatory submissions across US, EU, Japan, and ROW markets

Required Skills

  • Strong regulatory affairs and analytical science expertise
  • Knowledge of FDA SUPAC, ICH guidelines, and GMP
  • Experience in dissolution investigations
  • Team management and project leadership capabilities
  • Good presentation and client communication skills

3. Regulatory Operations Specialist II โ€“ Fortrea

  • Location: Mumbai
  • Job Type: Full-Time
  • Experience Required: 4โ€“7 Years
  • Qualification: B.Pharm, M.Pharm, Pharmaceutics, Packaging or related science field
  • Application Deadline: May 15, 2026

Key Responsibilities

  • Support developmental and comparative dissolution projects
  • Prepare technical protocols and analytical reports
  • Conduct dissolution investigations and data interpretation
  • Coordinate with CROs and contract laboratories
  • Support audits, SOPs, and quality processes

Skills Required

  • Regulatory affairs knowledge
  • GMP and pharmaceutical lifecycle understanding
  • Strong analytical and documentation skills
  • Experience in dissolution testing and formulation science

4. Regulatory Operations Specialist III โ€“ Fortrea

  • Location: Mumbai
  • Job Type: Full-Time
  • Experience Required: 7โ€“9 Years
  • Qualification: B.Pharm, M.Pharm, Packaging, Polymer, Printing or related science degree
  • Application Deadline: May 15, 2026

Key Responsibilities

  • Lead analytical and regulatory operations activities
  • Manage dissolution studies and regulatory documentation
  • Support audits and process improvements
  • Collaborate with cross-functional pharmaceutical teams
  • Maintain compliance with GMP and ICH-GCP guidelines

Preferred Skills

  • Leadership and project management experience
  • Knowledge of electronic data management systems
  • Strong quality review and documentation capabilities
  • Good communication and client handling skills

Why Join Fortrea?

Fortrea Official Website is a global CRO known for clinical development, regulatory services, pharmacovigilance, and analytical science support for pharmaceutical and biotechnology companies worldwide.

Employee Benefits

  • Global CRO exposure
  • Remote and hybrid opportunities
  • Career growth in pharmacovigilance and regulatory affairs
  • International client interaction
  • Learning opportunities in regulatory compliance and analytical science
  • Competitive salary and corporate benefits

Salary Expectations

RoleEstimated Salary Range
Workflow Analystโ‚น5 โ€“ โ‚น8 LPA
Regulatory Operations Specialist IIโ‚น8 โ€“ โ‚น14 LPA
Regulatory Operations Specialist IIIโ‚น14 โ€“ โ‚น20 LPA
Regulatory Operations Principal Specialistโ‚น18 โ€“ โ‚น28 LPA

Salary may vary based on experience, skill set, and interview performance.


How to Apply

Application Link For Workflow Analyst

Application Link For Regulatory Operations Specialist II

Application Link For Regulatory Operations Specialist III

Application Link For Regulatory Operations Principal Specialist

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