Fortrea Hiring Regulatory Operations Assistant I – Mumbai
Are you seeking Fortrea regulatory careers in Mumbai, regulatory affairs entry-level jobs, or pharmaceutical documentation specialist vacancies? Leading global clinical research organization (CRO) Fortrea is inviting online applications for the post of Regulatory Operations Assistant I based at its Mumbai facility.
This regulatory dossier compilation, electronic document management system (EDMS), GxP compliance tracking, and analytical documentation review vacancy is open to science postgraduates, pharmacy graduates, and PhD candidates holding B.Pharm, M.Pharm, or Masters in Life Sciences degrees. Candidates with 0 to 3 years of experience in regulatory operations, quality assurance, analytical chemistry documentation, or drug development are eligible to apply. To learn how to structure your clinical study concepts or laboratory analytics project summaries into an ATS-friendly format, check out our guide on how to apply for healthcare and pharma jobs.
📋 Job Overview
- Company: Fortrea
- Position: Regulatory Operations Assistant I
- Job Requisition ID: 263254
- Job Location: Mumbai, Maharashtra, India
- Employment Type: Full-Time
- Experience: 0 – 3 Years (Freshers can apply)
- Qualification: B.Pharm / M.Pharm / MSc Life Sciences / Ph.D
- Expected CTC: ₹4,00,000 – ₹7,0,000 per annum (Depending on experience)
💼 Key Responsibilities
Regulatory Operations & Document Submissions
- Support the preparation, assembly, compilation, and review of regulatory submission dossiers.
- Assist in formatting submission packets for global health agencies including US FDA, EMA (Europe), and PMDA (Japan).
- Maintain accurate records, specification guides, and change control logs in Electronic Document Management Systems (EDMS).
- Ensure complete alignment with regulatory standards including GMP, GLP, GDP, and international ICH guidelines.
- Coordinate onboarding activities and support tracking of departmental training records.
Analytical Documentation Support
- Review and verify analytical laboratory documents including API assay reports, impurity logs, and residual solvent tests.
- Document dissolution profiles, blend uniformity statistics, and content uniformity parameters.
- Support filing of cleaning validation logs, process validations, and device calibration records.
- Work alongside laboratory documentation teams using analytical data from HPLC, UPLC, Gas Chromatography (GC), and dissolution testing.
To build a strong understanding of drug regulatory pathways, product lifecycles, and agency structures, read our guide on how to Crack Your Regulatory Affairs Interview.
🎓 Required Qualifications & Skills
- Education: B.Pharm, M.Pharm, Master's degree in Life Sciences, or Ph.D. in related scientific fields.
- Experience: 0 to 3 years. Freshers with baseline understanding of pharmaceutical documentation are welcome.
- Technical Skills: Practical knowledge of GxP standards, regulatory submission guidelines, and document reviews.
- Preferred Assets: Certification in Regulatory Affairs or exposure to Regulatory Information Management Systems (RIMS).
- Communication: Good written and verbal English communication with high attention to detail.
- Tool Familiarity: Proficiency in Microsoft Word, Excel, and electronic document repositories.
To explore pharmacy pathways, registration guidelines, and global career opportunities, check out our comparison on B.Pharm Careers in India vs USA.
🎁 Why Join Fortrea?
- Gain hands-on exposure to global health authority submissions (US, EU, Japan, and ROW).
- Work with a leading multinational clinical research organization handling diverse drug pipelines.
- Structured professional development programs covering the drug development lifecycle.
- Collaborative workplace environment with opportunities to work alongside global regulatory teams.
To evaluate your knowledge of drug safety regulations, tracking systems, and clinical monitoring, try our interactive Clinical Research Associate (CRA) Quiz.
📝 Resume Tips for Fortrea Candidates
- Mention Document Standards: Highlight familiarity with eCTD structures, drug master files (DMF), or IND/NDA submission concepts.
- Detail Lab Software: List software or instruments you operated during lab projects, such as HPLC, UPLC, or Empower software.
- Include QMS Keywords: Use keywords like GMP, GDP, SOP, Quality Review, and Documentation Control in your skills profile.
💬 Fortrea Regulatory Operations Assistant Interview Questions
- Q1. What is the difference between an IND and an NDA in regulatory affairs?
Answer Guidance: An IND (Investigational New Drug) application is submitted before clinical trials begin on humans to secure permission to test the drug candidate. An NDA (New Drug Application) is submitted after clinical trials are completed to seek marketing approval from the regulatory agency. - Q2. What is eCTD and what are its five modules?
Answer Guidance: eCTD (electronic Common Technical Document) is the international standard format for submitting dossiers to health authorities. It consists of Module 1 (Administrative and prescribing information), Module 2 (Summaries), Module 3 (Quality/CMC), Module 4 (Non-clinical study reports), and Module 5 (Clinical study reports). - Q3. Why is data integrity critical in regulatory operations and analytical documentation?
Answer Guidance: Data integrity ensures that all submitted analytical and clinical data is ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate). Accurate documentation prevents compliance flags, audits failures, and delays in drug approvals from regulatory agencies.
📖 How to Apply?
Before submitting your application, please read our step-by-step guidance on how to navigate the Workday registration portal, fill out required forms, and format your application profile:
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Want to build a professional ATS-friendly resume tailored for Regulatory Operations, Quality Assurance, or Regulatory Affairs roles? Message us directly on our LinkedIn Company Page with the phrase "I want Resume Builder Service", and our expert team will connect with you:
📲 Message Us on LinkedIn🚀 Direct Application Link
If you are ready with your documents, apply directly via the official Fortrea Workday careers portal:
Apply Online – Fortrea Careers (Job Requisition 263254)📄 Try Free ATS Resume Analyzer & Builder
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🚀 Launch Free ATS Resume Tool❓ Frequently Asked Questions
Q. Are fresh pharmacy graduates eligible for this Fortrea role?
Yes, candidates with 0 years of experience who hold a B.Pharm, M.Pharm, or MSc in Life Sciences are eligible to apply.
Q. Where is this position located?
This is a full-time position based at Fortrea's office facility in Mumbai, Maharashtra.
Q. What technical documentation skills will I learn in this role?
You will gain hands-on training in compiling eCTD dossiers, managing files within Electronic Document Management Systems (EDMS), and reviewing quality assurance/analytical documentation.
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