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Fortrea is hiring Regulatory Operations Assistant I in Pune and Mumbai for freshers and early-career professionals with a Bachelor’s in Pharmacy or related science degrees. This role offers an exciting opportunity to support global pharmaceutical regulatory submissions, ensure compliance with international guidelines, and gain hands-on experience across product lifecycle management.
If you are detail-oriented, proactive, and passionate about regulatory affairs in the pharmaceutical sector, this is the perfect entry point to launch your career.
Key Responsibilities
As a Regulatory Operations Assistant I, you will be responsible for:
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- Preparing, compiling, and reviewing CMC (chemistry, manufacturing, and controls) and other regulatory documents for product registrations across the US, EU, Japan, and ROW.
- Creating, revising, and approving raw material and packaging specifications.
- Coordinating with cross-functional teams for change control, out-of-specification (OOS), and out-of-trend (OOT) investigations.
- Supporting financial data management, supplier data coordination, and purchase order creation.
- Assisting in global labeling projects, QC activities, stability data evaluation, and dissolution profile reporting.
- Conducting literature surveys to prepare documents supporting APIs, excipients, and drug products.
- Ensuring regulatory compliance in computerized system validation (CSV) and software updates.
- Maintaining training and documentation records as per Fortrea and client standards.
- Escalating unresolved issues promptly to internal and external stakeholders.
Required Qualifications
- Bachelor’s degree in Pharmacy or related science (Master’s/PhD preferred).
- 0–1 year of experience in Regulatory Affairs, Quality Assurance, Analytical Science, or Pharmaceutics.
- Knowledge of pharmaceutical product lifecycle, GxP, ICH, and GCP guidelines.
- Proficiency in Microsoft Office and document management tools.
- Strong analytical, organizational, and time management skills.
- Excellent interpersonal and communication skills.
Preferred Qualifications:
- Diploma or certification in Regulatory Affairs.
- Experience with Regulatory Information Management (RIM) systems and MIS.
Benefits
- Exposure to global regulatory submissions and product lifecycle management.
- Professional growth and training in Regulatory Affairs and Quality Assurance.
- Opportunity to work with cross-functional teams and international clients.
- Competitive entry-level salary and performance-based incentives.
How to Apply
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