🔹 Fortrea
| Published on: 18th July 2025
📌 Position: Regulatory Operations Associate II
👥 Experience: 2–5 years (Professionals Only)
🎓 Qualification: B.Pharm / M.Pharm / Life Sciences / Engineering / Packaging or related fields
🔍 Why Choose Careers@Pharma?
Verified pharma jobs posted daily
Tailored opportunities for freshers & professionals
Direct application details provided
Trusted by students and job seekers nationwide
About Fortrea:
Fortrea is a globally renowned Contract Research Organization (CRO) that partners with pharmaceutical, biotech, and medical device companies to advance innovative treatments. Known for excellence in clinical research and regulatory compliance, Fortrea fosters a people-first culture focused on innovation, patient safety, and quality execution in all areas of drug development.
Position: Regulatory Operations Associate II
Job Type: Full-Time
Job ID: 252255
Key Responsibilities:
Prepare, compile, and review regulatory documents, including CMC for global submissions
Develop raw material and packaging specifications
Evaluate change controls, perform impact assessments, and coordinate implementation strategies
Support labeling, stability analysis, dissolution profiling, and regulatory documentation
Manage supplier data, financial records, and purchase orders
Handle investigation reports, import licenses, and document control
Assist in quality assurance documentation, training records, and system validations
Maintain regulatory compliance metrics and promote process improvement
Eligibility Criteria:
Minimum Requirements:
Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or Packaging
2–5 years of relevant industry experience in Regulatory Affairs, QA, Pharmaceutics, or Analytical R&D
Strong knowledge of GxP, ICH guidelines, and pharma lifecycle management
Excellent documentation and communication skills
Preferred:
Master’s or PhD in a relevant field
Diploma or certification in Regulatory Affairs
Familiarity with MIS, RIM tools, or document management systems
How to Apply:
🔗 Apply Online: Fortrea Careers – Regulatory Operations Associate II
🆔 Search by Requisition ID: 252255
📌 Note: This is an online application only. Walk-ins are not accepted.