Latest Pharma Jobs at Fortrea l Apply Now for Regulatory Operations Assistant Role
Fortrea, a global clinical research and pharmaceutical solutions provider, is hiring Regulatory Affairs Associates in Pune and Mumbai. This role involves preparing, compiling, and reviewing regulatory documents to support global product development and submissions across the US, EU, Japan, and ROW markets. If you have a B.Pharm, M.Pharm, or a science degree with 1–2 years of experience, this is your chance to build a rewarding career in regulatory affairs with one of the most trusted healthcare organizations.
- Job Posting: Regulatory Affairs Associate | Fortrea
- Locations: Pune & Mumbai
- Time Type: Full Time
- Requisition ID: 254598
- Application Deadline: September 6, 2025
Job Overview
Responsible for creation, revision, compilation, and approval of specifications/documents for submission to US, EU, Japan, and ROW health authorities, along with oversight of the same.
Summary of Responsibilities
- Prepare, compile, and review product quality (CMC) and other regulatory documents for product registration and lifecycle maintenance.
- Create/revise/approve raw material and packaging specifications.
- Coordinate with cross-functional teams for evaluation/impact assessment of change control, OOS/OOT, and related documentation.
- Support financial data management, supplier data handling, PO creation, and labeling document updates.
- Conduct stability data evaluation, dissolution profile review, and literature surveys.
- Draft investigation reports, manage records, and support import license documentation.
- Ensure compliance with regulatory guidelines, GxP, ICH-GCP, and company SOPs.
- Track and maintain metrics, perform quality checks, and mentor new associates.
Qualifications
- Education: B.Pharm, M.Pharm, or Master’s/PhD in related sciences.
- Experience: 1–2 years in Regulatory Affairs, Quality Assurance, Analytical Sciences, Pharmaceutics, or material management.
- Skills: Knowledge of drug development and manufacturing processes, regulatory requirements, Microsoft Office, and document management tools.
- Preferred: Diploma/certification in Regulatory Affairs, knowledge of MIS or Regulatory Information Management systems.
Work Environment: Office-based or remote, with no special physical demands.
Fortrea offers a supportive workplace that values collaboration, compliance, and continuous learning.
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