Website Dr. Reddy’s Laboratories Ltd.
About Dr. Reddy’s Laboratories Ltd.
Dr. Reddy’s Laboratories Ltd., a global leader in pharmaceuticals, is driven by the purpose – Good Health Can’t Wait. Established in 1984, we are committed to accelerating access to affordable and innovative medicines, positively impacting over 1.5 billion patients by 2030.
We are inviting passionate and experienced professionals to join our Regulatory Affairs team at Hyderabad. This full-time, on-site opportunity offers a chance to contribute to product development and global regulatory strategy within our Integrated Product Development Organization (IPDO).
Position Overview
As a Regulatory Affairs Analyst, you will play a pivotal role in preparing, reviewing, and managing regulatory submissions for parenteral products. Your expertise will help ensure compliance, accelerate approvals, and support commercial launches across key global markets.
Key Responsibilities
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Regulatory Submissions: Prepare, compile, and review US ANDAs, 505(b)(2), EU, and Canada dossiers for injectable products as per current regulatory requirements.
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Deficiency Response Management: Draft and review responses to regulatory queries, controlled correspondences, and briefing books.
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Cross-functional Collaboration: Work closely with internal stakeholders including R&D, AR&D, SCM, FTO, CTO, and with external partners such as CMOs and CROs.
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Commercial Launch Support: Evaluate batch records, specifications, stability protocols, analytical methods, and PVPs to facilitate smooth product launches.
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eCTD & Labeling Compliance: Coordinate with eCTD and labeling teams to ensure accuracy and compliance in regulatory submissions.
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Risk Identification: Proactively identify and resolve issues during product development, ANDA filing, and post-approval phases.
Qualifications & Experience
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Education: M.Pharm, M.Sc, or Ph.D. in Pharmaceutical Sciences or related field.
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Experience: 3–6 years in Regulatory Affairs, preferably handling parenteral or injectable formulations.
Skills & Attributes
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Strong understanding of global regulatory guidelines and dossier preparation.
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Excellent written and verbal communication skills.
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Self-driven, detail-oriented, and proactive in problem-solving.
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Team-oriented mindset with exceptional collaboration and networking abilities.
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Ability to manage multiple priorities and deliver under tight deadlines.
Why Join Dr. Reddy’s
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🌍 Global Impact: Contribute to improving healthcare accessibility worldwide.
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🌿 Purpose-Driven Culture: Work for a company that prioritizes people, planet, and purpose.
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📈 Career Growth: Thrive in a future-ready, innovation-led environment.
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🧑🤝🧑 Inclusive Workplace: Experience a diverse, equal-opportunity organization.
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💰 Competitive Pay: Attractive salary in the range of INR 8–12 LPA, based on experience and expertise.
Application Process
Ready to make an impact in global healthcare?
Submit your application highlighting your regulatory affairs experience and passion for innovation.
📅 Application Deadline: November 13, 2025
📍 Location: Hyderabad, India
📞 Contact: For queries, reach out to our HR team via the company’s official career portal.