Dr. Reddy's Hiring Regulatory Affairs Analyst: Hyderabad IPDO
Are you seeking rewarding global dossier management opportunities via Dr. Reddy's Careers Hyderabad or Regulatory Affairs Analyst Jobs? Multinational pharmaceutical leader Dr. Reddy's Laboratories is inviting applications for the position of Regulatory Affairs Analyst at its Integrated Product Development Organization (IPDO) in Hyderabad.
This role requires 4 to 8 years of regulatory affairs experience, with specific exposure to US ANDA, 505(b)(2), EU, and Health Canada submissions for parenteral (sterile injectable) products. To structure a compliance-aligned resume that highlights your sterile dossier and eCTD expertise, read our guide on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Company | Dr. Reddy’s Laboratories Ltd. |
| Position | Regulatory Affairs Analyst – USA/Canada/EU |
| Department | Regulatory Affairs General (IPDO) |
| Job Location | Hyderabad, Telangana, India |
| Employment Type | Full-Time |
| Experience Required | 4 – 8 Years in Regulatory Affairs (Sterile Parenterals) |
| Qualifications | M.Pharm, M.Sc. (Pharmaceutical Sciences), PhD |
| Estimated Salary | ₹10,00,000 – ₹18,00,000 per annum (CTC) |
💼 Key Responsibilities
- Prepare and review US ANDA, 505(b)(2), European Union (EU), and Health Canada regulatory dossiers.
- Manage and execute complex regulatory submissions specifically for sterile parenteral (injectable) products.
- Draft and review deficiency responses (CRL/DR), controlled correspondences, and labeling documents.
- Review product labeling, briefing books, artworks, and change control procedures.
- Coordinate with cross-functional internal teams including R&D, Analytical R&D, SCM, Formulation Development, and CMOs.
- Provide strategic regulatory inputs throughout the product development and commercialization lifecycle.
- Review batch records, specifications, analytical methods, stability protocols, and validation protocols.
- Work closely with eCTD publishing teams to ensure submission compliance and validation.
To learn how global regulatory affairs and submission salaries compare with drug safety monitoring divisions, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Technical Skills
- Education: Master of Pharmacy (M.Pharm), Master of Science (M.Sc. in Pharmaceutical Sciences), or PhD in a relevant scientific discipline.
- Experience: 4 to 8 years of core experience in global regulatory affairs, specializing in sterile injectable applications.
- Regulatory Frameworks: In-depth knowledge of FDA regulations, EMA guidelines, Health Canada rules, and ICH frameworks.
- Submission Formats: Thorough understanding of eCTD structure, validation rules, and dossier publishing workflows.
- Dosage Forms: Hands-on exposure to regulatory review of injectable manufacturing batch records and stability data.
For pharmacy postgraduates evaluating global regulatory affairs careers against academic or clinical pathways, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join Dr. Reddy's IPDO?
- Dr. Reddy's is a top-tier Indian multinational operating in 66 countries.
- Exposure to the state-of-the-art IPDO research facility, driving complex generics and specialty portfolios.
- Work with highly experienced global regulatory experts and leading scientists.
- Excellent professional growth, competitive packages, and structural learning programs.
To evaluate your knowledge of clinical trials, protocol design, and documentation compliance standards, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 Regulatory Affairs vs Healthcare IT
Regulatory affairs analysts compile dossier packages for government reviews, whereas healthcare informatics supports electronic systems. To understand the differences, read our comparison on Healthcare IT vs Clinical Healthcare.
🚀 How to Apply?
Interested candidates should apply online directly on the official Dr. Reddy's career portal. Click the button below to submit your resume:
Apply Online - Dr. Reddy's Portal❓ Frequently Asked Questions
Q. What is the required experience for this Regulatory Affairs Analyst role?
Dr. Reddy's requires candidates to have between 4 to 8 years of regulatory affairs experience, specifically in sterile parenteral (injectable) products.
Q. Where will this role be based?
This is a full-time position located at Dr. Reddy's IPDO facility in Hyderabad, Telangana.
Q. What are the eligible qualifications?
Candidates holding M.Pharm, M.Sc. (Pharmaceutical Sciences), or PhD degrees are eligible to apply.
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