Looking to start your career in regulatory affairs jobs in India? Fortrea is hiring a Regulatory Operations Assistant I in Pune, offering an excellent opportunity for B.Pharm, M.Pharm, and life sciences graduates with 0โ1 years of experience. This role focuses on CMC documentation, regulatory submissions, and pharmaceutical lifecycle management, making it ideal for freshers aiming to enter the pharma regulatory domain.
With exposure to global submissions (US, EU, Japan), this is a strong entry point into pharmaceutical regulatory operations careers.
Job Overview
- Role: Regulatory Operations Assistant I
- Location: Pune, India
- Experience: 0โ1 years
- Industry: Pharmaceutical / Regulatory Affairs / CMC
- Company: Fortrea
- Employment Type: Full-time
Key Responsibilities (Regulatory Affairs & CMC)
As a Regulatory Operations Assistant, you will:
- Prepare, compile, and review CMC regulatory documents for global submissions
- Create and revise raw material and packaging specifications
- Support drug product lifecycle management and regulatory maintenance
- Coordinate with cross-functional teams for change control and impact assessment
- Assist in stability data evaluation and dissolution profile analysis
- Perform literature review for APIs, excipients, and formulations
- Support import licensing and regulatory documentation
- Manage OOS (Out of Specification) and OOT (Out of Trend) investigations
- Ensure compliance with ICH, GxP, and global regulatory guidelines
- Maintain documentation in Regulatory Information Management systems (RIMS)
Eligibility Criteria
Educational Qualification
- Bachelorโs in Pharmacy (B.Pharm) or related life sciences
- OR Masterโs degree (M.Pharm / MSc)
Experience
- 0โ1 year in:
- Regulatory Affairs
- Quality Assurance
- Analytical Sciences
- Pharmaceutics
Required Skills
- Knowledge of pharmaceutical product lifecycle & CMC documentation
- Understanding of ICH-GCP and GxP guidelines
- Strong analytical and documentation skills
- Familiarity with Microsoft Office & document management tools
- Good communication and stakeholder coordination abilities
- Detail-oriented with strong quality review skills
Preferred Qualifications
- Certification/Diploma in Regulatory Affairs
- Exposure to Regulatory Information Management Systems (RIMS)
- Knowledge of electronic data management systems
Salary & Benefits
- Estimated Salary: โน3.2 LPA โ โน5.5 LPA (entry-level regulatory roles in India)
- Opportunity to work on global regulatory submissions (US/EU/ROW)
- Strong career growth in regulatory affairs and CMC documentation
- Exposure to pharma product development lifecycle
- Professional training and skill development
Why This Role is Valuable
This Regulatory Operations Assistant job in Pune is ideal for freshers targeting:
- Regulatory Affairs career in pharma
- CMC documentation roles
- Entry into clinical research organizations (CROs)
It provides hands-on experience with global regulatory submissions, a high-demand skill in the pharmaceutical industry.
How to Apply
