Fortrea is a leading global contract research organization (CRO) providing comprehensive clinical development and regulatory solutions to pharmaceutical, biotechnology, and medical device companies. With a strong focus on innovation and compliance, Fortrea helps bring life-changing therapies to market efficiently.
Detailed Job Description
Job Title: Regulatory Operations Associate II
Location: Mumbai, India
Job Type: Full-time
Application Deadline: July 21, 2025 (3 days left)
Job ID: 252255
Key Responsibilities:
- Prepare, compile, and review CMC (Chemistry, Manufacturing, Controls) and regulatory documents for global submissions.
- Manage raw material & packaging specifications, change control assessments, and stability data evaluation.
- Support global labeling projects, stability studies, and dissolution profile reviews.
- Coordinate with cross-functional teams for regulatory compliance and supplier data management.
- Assist in Computerized System Validation (CSV) and regulatory documentation updates.
- Participate in Global Triage meetings and provide training to new associates.
- Ensure adherence to ICH-GCP, GxP guidelines, and regulatory requirements.
Eligibility Criteria:
Minimum Qualifications:
- Bachelor’s in Pharmacy, Science, or Engineering (B.Tech/Packaging/Polymer/Printing).
- 2-5 years of experience in Regulatory Affairs, Quality Assurance, or Analytical Science.
- Proficiency in Microsoft Office & Document Management tools.
- Strong organizational, analytical, and communication skills.
Preferred Qualifications:
- Master’s/PhD in Regulatory Affairs or related field.
- Knowledge of Regulatory Information Management (RIM) systems.
- Diploma/Certification in Regulatory Affairs or Packaging.
Benefits & Work Environment
- Office-based role in Mumbai with a collaborative work culture.
- Opportunities for career growth & skill development.
- Exposure to global regulatory compliance & pharmaceutical lifecycle management.
- Training & mentorship programs for professional advancement.
