Fortrea Hiring Regulatory Operations Specialist I in Mumbai | Apply Now
A rare chance has emerged for qualified candidates through Fortrea careers as the company seeks to fill the position of Regulatory Operations Specialist I in Mumbai. This role is ideal for individuals with a background in life sciences and significant experience in quality assurance, offering an opportunity to contribute to regulatory affairs and project management.
About the Company
Fortrea is a global contract research organization (CRO) that specializes in providing comprehensive solutions for clinical research and regulatory affairs. With a commitment to advancing healthcare through innovative research, Fortrea operates across various regions, including the US, EU, Japan, and other markets. The organization is dedicated to ensuring compliance and quality in the development of pharmaceuticals and medical devices.
Job Details:
- Position: Regulatory Operations Specialist I
- Location: Mumbai
- Job Type: Full time; office or remote work environment
- Official Requisition: 265581
- Posted On: 13 October 2026
- Application Deadline: 17 October 2026
- Note:: The application deadline stated in the source notification may have passed. Verify before applying.
Fortrea Job Description
The Regulatory Operations Specialist I will perform project management and regulatory affairs activities for Fortrea clients. As part of Fortrea careers, responsibilities include managing and coordinating regulatory operations for the creation, revision, compilation, and approval of specifications, regulatory, and labeling documents across the product lifecycle for submissions to health authorities.
Key Responsibilities
- Review and approve method qualification, validation, and transfer protocols and reports.
- Handle investigations and non-conformances.
- Manage quality issues, CAPA, and change controls for clients and their contract laboratories.
- Participate in QA CSQ, CAPA board, and quality improvement meetings.
- Support data-driven risk assessments and mitigation plans.
- Assist senior management with resourcing and support team members.
Eligibility Criteria
- Bachelor’s or Master’s degree in a scientific discipline (pharmaceutical, chemical, or biological sciences) or equivalent experience.
- At least 5–7 years of experience in the pharmaceutical industry, preferably in Quality Assurance.
How to Apply
Interested candidates should apply online on Fortrea’s official careers portal before 17 October 2026 at this link.
Why Join Fortrea
Joining Fortrea offers the opportunity to work in a dynamic environment focused on regulatory compliance and quality assurance. Employees are part of a dedicated team that plays a crucial role in supporting clients throughout the product lifecycle, ensuring that high standards are maintained in the pharmaceutical industry.
Fortrea is poised to welcome skilled professionals who meet the necessary qualifications for the Regulatory Operations Specialist I position. Interested candidates exploring Fortrea careers are encouraged to apply before the deadline to seize this opportunity to contribute to impactful regulatory operations.
