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Regulatory Operations Specialist Ii

Fortrea
Fortrea
0-2 years
Not Disclosed
10 April 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Operations Specialist II
Location: Mumbai
Category: Clinical
Job ID: 2447559


Summary of Responsibilities:

  • Perform Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) calculations and prepare related reports.

  • Conduct safety assessments for OTC (Over-The-Counter) / Self-care product formulas.

  • Assess the safety of raw materials used in pharmaceutical or personal care products.

  • Perform Extractables and Leachables (E&L) safety assessments.

  • Conduct impurity qualification to support regulatory compliance.

  • Prepare INCI-Toxicology profiles for OTC/Self-care ingredients.

  • Author the Non-Clinical Overview (Module 2.4) as part of regulatory submissions.

  • Conduct toxicological literature reviews and generate comprehensive reports.