Freshers Job Regulatory Operations Assistant I at Fortrea
Position: Regulatory Operations Assistant I
Organization: Fortrea
Qualification: B.Pharm, M.Pharm, M.Sc, Ph.D, or related Life Science degree
Location: Pune, Mumbai
Experience: 0–1 Years
Job Type: Full-Time
Application Mode: Online
Job ID: 255213
Application Deadline: October 17, 2025
Overview
Fortrea, a leading global contract research organization (CRO), is inviting applications for the position of Regulatory Operations Assistant I. This full-time opportunity is open for fresh graduates and early-career professionals with a background in pharmacy, life sciences, or related disciplines. Freshers Job Regulatory Operations Assistant I at Fortrea
As a Regulatory Operations Assistant, you will play a vital role in supporting the preparation, review, and submission of regulatory documents for global health authorities, including the US FDA, EMA, Japan, and other regions. This position offers excellent exposure to global regulatory operations, quality systems, and cross-functional collaboration within the pharmaceutical industry. Freshers Job Regulatory Operations Assistant I at Fortrea
Job Responsibilities
As a Regulatory Operations Assistant I, your responsibilities will include the following:
- Document Preparation and Review: Prepare, compile, and review product quality (CMC) and other regulatory documents for product development, submissions, and post-approval lifecycle maintenance.
- Specification Management: Create, revise, and approve raw material and packaging specifications along with other associated documents.
- Cross-Functional Coordination: Collaborate with multiple departments for evaluating and implementing change controls, reviewing documentation, and managing OOS, OOT, or other product-related changes.
- Data and Supplier Management: Support business plan creation, supplier data management, and purchase order (PO) processing.
- Labeling Support: Assist in the creation and update of global labeling documents, QC data, and related labeling project activities.
- Stability and Analytical Support: Participate in stability data evaluation, report preparation, and dissolution profile assessments as required.
- Research and Documentation: Conduct literature reviews and prepare regulatory documents for excipients, APIs, and drug products.
- Compliance and Validation: Support specification justification, laboratory quality levels, computerized system validation (CSV), and software upgrades.
- Guideline Adherence: Stay up to date with international regulatory guidelines and ensure consistency with global pharmaceutical standards.
- Issue Escalation: Escalate unresolved or critical issues to internal and external stakeholders in a timely manner.
- Training and Documentation: Maintain training-related documentation as per Fortrea and client-specific requirements.
- Other Duties: Perform additional responsibilities as assigned by management to support team goals.
- Freshers Job Regulatory Operations Assistant I at Fortrea
Qualifications and Requirements
Educational Qualification:
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field (M.Pharm, M.Sc, or Ph.D preferred).
- A Diploma or Certification in Regulatory Affairs will be an added advantage.
Experience:
- 0–1 years of experience in Regulatory Affairs, Quality Assurance, Analytical Science, or related disciplines.
- Freshers with strong technical and analytical skills are encouraged to apply.
Technical Skills:
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Experience with document management and publishing tools is desirable.
- Knowledge of GxP, ICH, and GCP guidelines preferred.
- Familiarity with Management Information Systems (MIS) and electronic data management systems is advantageous.
Core Competencies:
- Strong communication and organizational skills.
- Excellent attention to detail and review accuracy.
- Analytical thinking and problem-solving capabilities.
- Customer focus with a proactive and goal-oriented approach.
- Ability to manage multiple priorities and meet deadlines effectively.
Preferred Qualifications
- Advanced degree (M.Pharm, M.Sc, or Ph.D) in a relevant field.
- Exposure to regulatory information management systems.
- Certification or diploma in Regulatory Affairs.
- Understanding of global pharmaceutical regulations and product lifecycle management.
- Freshers Job Regulatory Operations Assistant I at Fortrea
Work Environment
- Type: Office or Remote (depending on project requirements).
- Physical Demands: No special factors at this time.
Fortrea offers a collaborative work culture focused on innovation, integrity, and excellence. The organization provides opportunities for continuous learning and professional growth in global drug development and regulatory operations. Freshers Job Regulatory Operations Assistant I at Fortrea
How to Apply
Interested candidates can apply online through the official Fortrea careers portal before the deadline Freshers Job Regulatory Operations Assistant I at Fortrea
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