Fortrea, a leading global clinical research organization, is inviting applications for the position of Regulatory Operations Associate II at its Mumbai office. This full-time role offers an exciting opportunity for professionals with 2–5 years of experience in regulatory affairs, quality assurance, pharmaceutics, or related fields.
If you have a strong understanding of pharmaceutical regulatory processes and are looking to work in a globally recognized organization, this could be the ideal next step in your career.
Job Details:
- Position: Regulatory Operations Associate II
- Location: Mumbai, India
- Job Type: Full-Time
- Application Deadline: July 21, 2025
- Job Requisition ID: 252255
Key Responsibilities:
- Prepare, compile, and review regulatory documents (including CMC) to support product registration and lifecycle maintenance across global markets.
- Develop and maintain raw material and packaging specifications.
- Evaluate change controls, perform impact assessments, and coordinate implementation strategies across departments.
- Support labeling projects, stability data analysis, dissolution profiling, and creation of regulatory documents.
- Manage supplier data, purchase orders, financial data, and business plan files.
- Collaborate on document control, investigation reports, import licensing, and change evaluation.
- Assist in document preparation and justification for specifications, computerized system validations, and quality assurance activities.
- Support global triage meetings, onboarding of new associates, and training documentation.
- Ensure adherence to regulatory requirements and internal SOPs through consistent quality processes.
- Maintain metrics and documentation for compliance and continuous improvement.
Qualifications:
Minimum Requirements:
- Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Packaging, or equivalent field.
- 2–5 years of relevant industry experience (Regulatory Affairs, QA, Analytical, or Pharmaceutics).
- Strong knowledge of pharmaceutical product lifecycle, GxP, and ICH guidelines.
- Proficiency in Microsoft Office and document management tools.
- Good communication, analytical thinking, and organizational skills.
Preferred:
- Advanced degree (Master’s or PhD) in relevant field.
- Diploma or Certification in Regulatory Affairs.
- Experience with Management Information Systems (MIS) or Regulatory Information Management (RIM) tools.
Why Join Fortrea?
At Fortrea, you’ll work in a supportive and innovation-driven environment. The company values precision, collaboration, and continuous learning. As part of the regulatory operations team, you’ll play a crucial role in ensuring global regulatory compliance and advancing healthcare solutions.
📅 Last Date to Apply: July 21, 2025
📍 Location: Mumbai
🆔 Job Requisition ID: 252255
Apply now and take the next step in your regulatory career with Fortrea!
