Hurry! Only 6 days left to apply. Fortrea is hiring a Regulatory Operations Assistant I in Mumbai. This full-time role is perfect for freshers and early-career professionals seeking pharma jobs in Regulatory Affairs, Quality Assurance, and Analytical Development.
Ideal for those looking for pharmaceutical careers in India with exposure to global regulatory submissions.
Contents
About the Company
Fortrea is a leading global Contract Research Organization (CRO) dedicated to advancing clinical development and bringing life-changing therapies to patients faster. Formerly part of Labcorp Drug Development (and Covance), Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and regulatory solutions to biopharma, biotech, and medical device companies across 90+ countries.
With over 30 years of experience, Fortrea combines scientific rigor, operational excellence, and innovation to support drug development. The company offers excellent pharmaceutical careers in India in a dynamic, patient-focused environment.
Job Details
- Company Name: Fortrea
- Experience: 0–3 years (0–1 year preferred for freshers)
- Qualification: Bachelor’s in Pharmacy or related science degree (or equivalent); Advanced degree (M.Sc/PhD) advantageous
- Location: Mumbai, Maharashtra, India
- Work Type: Full-time (Office or Remote possible)
Job Description
Fortrea is hiring a Regulatory Operations Assistant I responsible for creation, revision, compilation, and approval of specifications and documents for submission to US, EU, Japan, and ROW health authorities. The role supports regulatory operations, analytical testing, and compliance activities in a global CRO environment.
End Date to Apply: April 15, 2026
Regulatory Operations Assistant I
- Department: Regulatory Operations / Quality Assurance
- Market: Contract Research Organization (CRO)
- Role: Regulatory Operations Assistant I
- Experience: 0–3 years
- Education/Qualification: Bachelor’s in Pharmacy or related science (or equivalent)
Skills/Qualifications
- Bachelor’s in Pharmacy or related science degree
- 0–3 years experience in Regulatory Affairs, Quality Assurance, Analytical Science, or Pharmaceutics
- Technical proficiency in Microsoft Office and document management tools
- Good understanding of pharmaceutical product lifecycle, GxP, ICH-GCP, and GMP guidelines
- Excellent English communication skills (oral and written)
- Strong organizational, time management, and analytical abilities
- Proactive, precise, goal-oriented with customer focus
- Knowledge of Regulatory Information Management systems preferred
- Diploma/Certification in Regulatory Affairs is a plus
Key Responsibilities
- Create, revise, compile, and approve regulatory specifications and documents
- Perform analysis of Assay, Related Substances, Dissolution, and other tests for API and Finished Products
- Conduct cleaning validation and process validation analysis
- Ensure compliance with GMP, GLP, GDP, cGMP, and ICH guidelines
- Handle instruments including HPLC, UPLC, GC, Dissolution, Particle Size Analyzer, Karl Fisher, etc.
- Maintain training documentation as per Fortrea and client requirements
- Support onboarding, training, and mentoring of new associates
- Follow safety practices and perform tasks assigned by HOD
- Support submissions to US, EU, Japan, and ROW health authorities
Benefits/Perks
- Career growth in global regulatory operations and clinical development
- Exposure to international regulatory submissions and pharmaceutical lifecycle
- Opportunities for learning and mentoring in a leading CRO
- Collaborative work culture focused on innovation and patient outcomes
- Work in office or remote environment
- Contribution to drug development that impacts global health
How to Apply
Apply directly through the official Fortrea Careers portal using Job Requisition ID 26655 before the deadline: April 15, 2026.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Fortrea Career page.
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Apply now – only a few days left to join Fortrea and build your career in regulatory operations!
Why You Should Join
Fortrea provides a supportive environment where freshers and early-career professionals can gain hands-on experience in regulatory document management and analytical testing. With a strong legacy in clinical research and a focus on innovation, the company offers long-term career stability, continuous learning, and global exposure in the fast-growing CRO and pharmaceutical sector.
FAQs
What is the last date to apply for the Regulatory Operations Assistant I position?
The application deadline is April 15, 2026 (only 6 days left).
What qualification is needed for this pharma job in Mumbai?
Bachelor’s in Pharmacy or related science degree (or equivalent). Relevant experience can substitute in some cases.
Is prior experience mandatory?
No, 0–3 years of experience is acceptable. Freshers with strong academic background are encouraged to apply.
What work environment is offered for this role?
The position is based in an office environment in Mumbai, with possible remote working options.
I am interested
I’m interested