Looking for Regulatory Affairs Analyst jobs in Hyderabad? Dr. Reddy’s Laboratories is hiring experienced Regulatory Affairs professionals for its Integrated Product Development Organization (IPDO). This opportunity is ideal for professionals with 4โ8 years of Regulatory Affairs experience in US ANDA, 505(b)(2), EU, and Canada dossier submissions for sterile injectable (Parenteral) products.
Candidates with M.Pharm, M.Sc., or PhD qualifications and expertise in global regulatory submissions, ICH guidelines, FDA regulations, and eCTD publishing are encouraged to apply.
Job Highlights
| Particular | Details |
|---|---|
| Position | Regulatory Affairs Analyst โ USA/Canada/EU |
| Company | Dr. Reddy’s Laboratories Ltd. |
| Department | Regulatory Affairs General (IPDO) |
| Job Location | Hyderabad, Telangana |
| Experience | 4โ8 Years |
| Qualification | M.Pharm, M.Sc., PhD |
| Industry | Pharmaceutical |
| Employment Type | Full Time |
Key Responsibilities
The selected candidate will be responsible for:
- Preparing and reviewing US ANDA, 505(b)(2), European Union, and Canada regulatory dossiers.
- Handling regulatory submissions for Parenteral (Injectable) products.
- Preparing deficiency responses and regulatory strategy documents.
- Reviewing labeling documents, artworks, briefing books, and controlled correspondences.
- Coordinating with cross-functional teams including:
- Research & Development (R&D)
- Analytical R&D
- Supply Chain Management
- Formulation Development
- Clinical Teams
- External CROs and CMOs
- Supporting commercial product launches through regulatory review.
- Reviewing batch records, specifications, analytical methods, stability protocols, and validation plans.
- Working with eCTD publishing teams to ensure regulatory-compliant submissions.
- Providing strategic regulatory inputs throughout product development.
Required Qualifications
Applicants should possess:
- M.Pharm
- M.Sc. (Pharmaceutical Sciences)
- PhD (Relevant Discipline)
Experience Required
- 4โ8 years in Regulatory Affairs
- Experience with global pharmaceutical submissions
- Hands-on knowledge of injectable products
Required Technical Skills
Candidates should have strong knowledge of:
- US ANDA submissions
- 505(b)(2) applications
- EU Regulatory Procedures
- Canada Regulatory Requirements
- eCTD Publishing
- ICH Guidelines
- FDA Guidance Documents
- European Medicines Agency (EMA) Regulations
- Health Canada Regulations
- Pharmaceutical Manufacturing
- Intellectual Property
- Quality Systems
- Pharmacopoeias
- Product Development Lifecycle
Soft Skills
Dr. Reddy’s is looking for professionals with:
- Excellent written and verbal communication
- Strong analytical thinking
- Problem-solving abilities
- Team collaboration
- Stakeholder management
- Planning and execution skills
- Quick learning ability
- High performance orientation
Why Join Dr. Reddy’s?
Dr. Reddy’s Laboratories is among India’s leading multinational pharmaceutical companies with operations across 66 countries. Employees get opportunities to:
- Work on global regulatory submissions
- Build expertise in US, EU and Canada markets
- Collaborate with international regulatory teams
- Contribute to innovative pharmaceutical products
- Develop long-term career growth in Regulatory Affairs
The company promotes diversity, equal opportunity, learning, and innovation.
Salary Expectation
Based on current Regulatory Affairs market trends in Hyderabad, professionals with 4โ8 years of experience can expect an estimated salary of:
โน10,00,000 โ โน18,00,000 per annum (CTC)
Actual compensation depends on experience, skills, and internal company policies.
How to Apply
