Apply for Regulatory Operations Assistant I at Fortrea Mumbai. Check eligibility, salary, freshers welcome, and apply online before deadline today.
Introduction
The Regulatory Operations Assistant I at Fortrea 2026 offers a strong entry point for candidates interested in regulatory affairs and pharmaceutical operations. This opportunity is ideal for freshers and professionals with limited experience who want to build a career in global regulatory documentation and compliance. Working with a reputed organization like Fortrea provides exposure to international standards and real-world pharmaceutical processes.
Job Overview
| Job Title | Regulatory Operations Assistant I |
|---|---|
| Company Name | Fortrea |
| Location | Mumbai, India |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Operations |
| Experience Required | 0–3 Years |
| Education | B.Pharm / Life Sciences / M.Pharm / PhD |
| Salary | As per company standards |
Company Overview
Fortrea is a leading global clinical research organization that provides comprehensive solutions across drug development, regulatory services, and clinical trials. The company works closely with pharmaceutical, biotechnology, and healthcare organizations to support the development and approval of safe and effective medicines. Known for its scientific expertise and regulatory excellence, Fortrea plays a vital role in accelerating healthcare innovation worldwide.
Job Location & Employment Type
- Location: Mumbai, Maharashtra
- Employment Type: Full-Time
Open Positions / Department Details
The position is part of the Regulatory Operations team, which focuses on preparing and managing documentation for submissions to global health authorities. The team ensures compliance with international standards and supports pharmaceutical product approvals across multiple regions.
Key Roles & Responsibilities
- Prepare, review, and compile regulatory documents for submissions to global authorities such as the US, EU, Japan, and other regions
- Ensure compliance with GMP, GLP, GDP, and ICH guidelines
- Perform analytical evaluations including assay, related substances, dissolution, and content uniformity
- Conduct testing for residual solvents and particle size analysis
- Operate instruments such as HPLC, GC, UPLC, Karl Fischer, pH meter, and analytical balance
- Support cleaning validation and process validation activities
- Maintain accurate training and regulatory documentation
- Assist in onboarding and mentoring new team members
- Coordinate with cross-functional teams to ensure timely submissions
- Perform additional tasks assigned by management
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy or Life Sciences
- OR Master’s degree or PhD in a related field
- Certification in Regulatory Affairs is preferred
Experience
- 0 to 3 years of relevant experience in regulatory affairs, quality assurance, analytical research, or pharmaceutical manufacturing
Skills Required
- Understanding of pharmaceutical product lifecycle
- Knowledge of GxP and ICH-GCP guidelines
- Familiarity with regulatory documentation and submission processes
- Proficiency in Microsoft Office tools
- Basic knowledge of regulatory information management systems
- Strong analytical and problem-solving skills
- Good communication and teamwork abilities
- Time management and organizational skills
- Attention to detail and quality focus
Salary & Benefits
- Salary: As per company standards
- Additional benefits may include health insurance, training programs, career growth opportunities, and exposure to global projects
Selection Process
- Application screening
- HR interview
- Technical interview
- Final selection
How to Apply
Candidates can apply through the official Fortrea online career portal. Ensure that your resume is updated with relevant qualifications and experience before submitting the application.
Important Dates
- Last Date to Apply: April 15, 2026
Why Apply for This Job?
- Opportunity to work with a globally recognized clinical research organization
- Exposure to international regulatory standards and submission processes
- Suitable for freshers looking to enter regulatory affairs
- Hands-on experience with analytical techniques and instruments
- Strong career growth potential in pharmaceutical operations and compliance
- Opportunity to work on global pharmaceutical projects
FAQs
Who can apply for this job?
Candidates with B.Pharm, M.Pharm, or other life science degrees with 0–3 years of experience can apply.
What is the salary range?
The salary is offered as per company standards and depends on qualifications and experience.
Is experience required?
No, freshers are eligible to apply, although relevant experience is an advantage.
How can I apply?
You can apply through the official Fortrea careers website.
What skills are needed?
Knowledge of regulatory guidelines, documentation skills, analytical abilities, and proficiency in MS Office are important.
Conclusion
The Regulatory Operations Assistant I at Fortrea 2026 is a valuable opportunity for candidates aiming to build a career in regulatory affairs. With exposure to global processes, compliance standards, and analytical practices, this role provides a solid foundation for long-term growth in the pharmaceutical industry. Interested candidates should apply before the deadline to take advantage of this opportunity.
Disclaimer
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