Lupin Limited, one of India’s leading global pharmaceutical companies, is hiring for the position of Officer – Regulatory Affairs (RA) at its Santacruz, Mumbai location. This opportunity is ideal for freshers or candidates with up to 1 year of experience looking to build a strong career in pharmaceutical regulatory submissions and compliance.
This role involves hands-on exposure to regulatory documentation, dossier compilation, labeling amendments, and product launch support, making it an excellent entry-level RA position in the pharmaceutical industry.
Key Responsibilities – Officer Regulatory Affairs (RA)
- Support regulatory submissions, including Annual Reports and Supplements
- Assist in New Product Launch (NPL) regulatory activities
- Manage Labeling Amendments as per regulatory requirements
- Prepare and submit responses to DRL (Discipline Review Letter) and IR (Information Request)
- Support Complete Response Amendments
- Assist in dossier compilation and regulatory documentation
- Ensure compliance with global quality guidelines and regulatory standards
- Coordinate with internal stakeholders to ensure timely submissions
Primary Keywords Used:
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Eligibility Criteria & Qualifications
Education
- Bachelor’s Degree in Pharmacy (B.Pharm)
OR - Master’s Degree in Chemistry
Experience
- Fresher to 1 year of experience
- Exposure to dossier compilation and awareness of quality guidelines is preferred
Required Competencies
- Customer Centricity
- Collaboration & Stakeholder Management
- Process Excellence
- Strategic Agility
- Innovation & Creativity
- Result Orientation
Long-tail Keywords:
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Why Join Lupin? – Employee Benefits
- Work with a top-tier global pharmaceutical company
- Strong learning curve in Regulatory Affairs & Compliance
- Exposure to drug submissions and product lifecycle management
- Collaborative and process-driven work environment
- Competitive salary aligned with industry standards
- Career growth opportunities in Regulatory Affairs & Global Submissions
Salary Details
- Estimated Salary Range: ₹3,00,000 – ₹5,00,000 per annum
(Based on industry standards for entry-level Regulatory Affairs roles in Mumbai)
Job Location
📍 Santacruz, Mumbai, Maharashtra, India
How to Apply
