Fortrea Hiring Regulatory Operations Assistant I in Mumbai | B.Pharm Freshers Apply

Fortrea is hiring for the position of Regulatory Operations Assistant I at its Mumbai location. This is an excellent opportunity for freshers and candidates with up to 3 years of experience in regulatory affairs, quality assurance, or pharmaceutical sciences.

📍 Job Details

• Position: Regulatory Operations Assistant I
• Location: Mumbai
• Job Type: Full-Time
• Experience: 0–3 Years
• Application Deadline: April 15, 2026
• Job ID: 26655

Job Responsibilities

• Creation, revision, and compilation of regulatory documents for global submissions (US, EU, Japan, ROW).
• Ensure compliance with GMP, GLP, GDP, cGMP, and ICH guidelines.
• Perform analytical testing including:
  • Assay & related substances
  • Dissolution & content uniformity
  • Residual solvents & particle size analysis
• Work on cleaning validation and process validation.
• Handle instruments such as HPLC, GC, UPLC, Karl Fischer, Dissolution Apparatus, Particle Size Analyzer.
• Maintain training documentation as per company and client requirements.
• Support onboarding and mentoring of new team members.
• Perform tasks assigned by management or HOD.

Qualifications

• B.Pharm / M.Pharm / MSc or related science degree
• Advanced degrees (Masters/PhD) are also acceptable
• Strong English communication skills

Experience Required

• 0–3 years in:
  • Regulatory Affairs
  • Quality Assurance
  • Analytical Sciences
  • Pharmaceutics
• Knowledge of:
  • Pharmaceutical product lifecycle
  • GxP & ICH-GCP guidelines
  • MS Office & document management tools

Preferred Skills

• Certification/Diploma in Regulatory Affairs
• Knowledge of MIS & Regulatory Information Management systems
• Strong analytical, organizational, and time management skills
• Attention to detail & quality-focused mindset
• Customer-focused and proactive approach

Work Environment

• Office-based or remote work setup
• Standard corporate environment
• No special physical demands

Why Join Fortrea?

• Global exposure in regulatory submissions
• Opportunity to work with international clients
• Strong learning and career growth environment
• Ideal role for freshers entering regulatory affairs

APPLY HERE