CMC & Regulatory Affairs Career Opportunity at Fortrea

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.

How to Apply

Application Link