Regulatory Operations Expert

About the role

Regulatory Operations team at Fortrea Scientific focuses on translating complex material and analytical data into robust CMC documentation supporting pharmaceutical product lifecycle. The role leads scientific content creation, risk assessments, and regulatory submissions while collaborating with manufacturing, quality, and regulatory stakeholders. Mumbai, hybrid work model with occasional travel (5-10%).

What you’ll do

• Own development of high-quality CMC documentation for raw materials, excipients, and process aids
• Translate analytical and chemical data into scientific justifications and risk assessments
• Ensure alignment with Quality-by-Design principles and regulatory guidelines
• Support technology transfer, PPQ, and commercial manufacturing activities
• Collaborate across MSAT, analytical development, formulation, manufacturing, and regulatory teams
• Maintain traceability of data and documentation throughout product lifecycle
• Engage with external suppliers and contract labs to verify scientific information

What you’ll bring

• 7-9 years experience in regulatory affairs, quality assurance, or analytical science
• 1+ year project management experience
• Strong expertise in analytical chemistry and material characterization
• Knowledge of pharmaceutical manufacturing processes and unit operations
• Experience drafting CMC documentation and regulatory submissions
• Proficiency with Microsoft Office and document management tools
• Excellent written and spoken English

Skills

Education

Bachelor's in Pharmacy or related science; Advanced degree (MSc or PhD) in Chemistry, Chemical Engineering, Material Science, or Pharmaceutical Sciences