Apply for Regulatory Operations Assistant I at Fortrea 2026. Check eligibility, salary, experience, and application process details online today now.
Introduction
The regulatory affairs domain is a crucial pillar of the pharmaceutical and clinical research industry. The Regulatory Operations Assistant I at Fortrea offers a great entry-level opportunity for candidates interested in regulatory submissions, documentation, and compliance processes. This role is ideal for freshers and early-career professionals aiming to build a strong foundation in global regulatory operations.
Job Overview
| Details | Information |
|---|---|
| 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 or related science degree |
| Salary | As per company norms |
Company Overview
Fortrea is a global contract research organization (CRO) focused on clinical development and regulatory solutions. The company partners with pharmaceutical and biotechnology organizations to streamline drug development processes, ensuring compliance with international regulatory standards across regions such as the US, Europe, and Japan.
Job Location & Employment Type
This role is based in Mumbai, India, and is a full-time position. The work environment is primarily office-based, with potential flexibility depending on company policies.
Open Positions / Department Details
The position is part of the Regulatory Operations team, where the selected candidate will assist in preparing and managing documents required for submission to global health authorities.
Key Roles & Responsibilities
- Prepare, compile, and revise regulatory documents for global submissions
- Ensure documentation compliance with US, EU, Japan, and ROW regulatory authorities
- Follow GMP, GLP, GDP, and cGMP guidelines
- Perform analytical testing including assay, dissolution, and content uniformity
- Handle laboratory instruments such as HPLC, GC, UPLC, Karl Fischer, and particle size analyzers
- Support validation processes including cleaning and process validation
- Maintain training documentation and regulatory records
- Assist in onboarding and mentoring new team members
- Collaborate with internal teams to ensure quality and compliance
- Perform additional tasks assigned by management
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy or related science field (mandatory)
- Master’s degree or PhD (preferred but not required)
- Certification in Regulatory Affairs is an added advantage
Experience
- 0 to 3 years of relevant experience in regulatory affairs, QA, or analytical science
- Freshers with strong academic background can apply
- Experience in pharmaceutical product lifecycle is desirable
Skills Required
- Basic understanding of regulatory guidelines (ICH, GxP, cGMP)
- Good analytical and problem-solving skills
- Strong documentation and review capabilities
- Proficiency in Microsoft Office and document management tools
- Effective communication and interpersonal skills
- Attention to detail and quality focus
- Ability to manage time and prioritize tasks
Salary & Benefits
- Salary: As per company norms
- Opportunity to work in global regulatory submissions
- Exposure to international health authority requirements
- Learning and development opportunities
- Career growth in regulatory affairs and clinical research
- Professional work environment
Selection Process
The hiring process generally includes:
- Resume screening
- HR interview
- Technical interview
- Final selection
How to Apply
Candidates can apply through the official Fortrea careers portal before the deadline. Ensure your resume highlights your knowledge of regulatory affairs, documentation, and analytical techniques.
Important Dates
- Last Date to Apply: April 15, 2026
Why Apply for This Job?
The Regulatory Operations Assistant I at Fortrea is a valuable opportunity for candidates starting their careers in regulatory affairs. This role provides exposure to global submission processes, compliance standards, and documentation systems. With structured learning and growth opportunities, it serves as a strong stepping stone for advanced roles in regulatory affairs and clinical research.
FAQs
1. Can freshers apply for this role?
Yes, freshers with a B.Pharm or related degree are eligible.
2. What experience is required?
0–3 years of experience in regulatory affairs, QA, or related fields.
3. What skills are important for this job?
Knowledge of regulatory guidelines, documentation skills, and analytical abilities.
4. Is a master’s degree mandatory?
No, but it is preferred and can enhance your profile.
5. What is the last date to apply?
The last date to apply is April 15, 2026.
Conclusion
The Regulatory Operations Assistant I role at Fortrea is an excellent entry-level opportunity for candidates interested in regulatory affairs and pharmaceutical compliance. With global exposure and career growth potential, this position can help you build a strong future in the pharma and CRO industry. Apply soon to secure your chance.
Disclaimer
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