Dr. Reddy’s Laboratories Regulatory Affairs Specialist Hiring at Hyderabad

Regulatory Affairs Specialist Jobs in Hyderabad – MPharm/MSc/PhD Graduates with 6–12 Years Experience

Explore Regulatory Affairs Specialist vacancy at Dr. Reddy’s Laboratories in Hyderabad for MPharm, MSc, or PhD holders with 6–12 years of experience. Apply now for on-premise roles in a global pharma leader.

Regulatory Affairs Specialist Opportunity at Dr. Reddy’s Laboratories – Hyderabad

Are you a seasoned Regulatory Affairs professional seeking a growth-oriented role in a globally recognized pharmaceutical company? Dr. Reddy’s Laboratories is hiring Regulatory Affairs Specialists at their Hyderabad location. This full-time, on-site opportunity is ideal for candidates with a strong educational background in MPharm, MSc, or PhD and 6–12 years of hands-on experience in regulatory operations.

Why Choose Dr. Reddy’s Laboratories?

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a multinational pharmaceutical giant driven by innovation, access, and sustainability. With a global footprint spanning over 66 countries and a workforce of more than 24,000 professionals, Dr. Reddy’s is committed to delivering affordable, high-quality medicines. The organization fosters a diverse and inclusive work environment and values integrity, transparency, and continuous learning.

Dr. Reddy’s aims to impact over 1.5 billion patients by 2030 through its initiatives rooted in science, people-first practices, and forward-looking governance.

Position Overview: Regulatory Affairs Specialist – IPDO

As part of the Integrated Product Development Organization (IPDO) team, the Regulatory Affairs Specialist will focus on parenteral products for global markets such as the US, EU, and Canada. The role involves preparing and reviewing regulatory dossiers, coordinating with internal and external stakeholders, and ensuring compliance with regional regulatory requirements.

Key Responsibilities

Regulatory Documentation and Compliance

• Prepare and review US ANDAs, 505(b)(2) applications, EU, and Canada dossiers
• Draft responses to deficiencies, controlled correspondences, briefing books, and labeling documentation
• Collaborate with eCTD and labeling teams to ensure timely submissions

Cross-Functional Coordination

• Work closely with R&D, AR&D, Supply Chain, FTO, CTO, and external vendors (CMOs, CROs)
• Provide regulatory strategy inputs during product development and commercial launch stages

Product Life Cycle Support

• Evaluate changes for commercial batches including batch records, specifications, analytical methods, and protocols
• Address open issues during product filing and development phases

Educational Qualifications & Desired Profile

 Minimum Qualification:

• MPharm (Master of Pharmacy)
• MSc (Master of Science in Life Sciences, Chemistry, etc.)
• PhD (Preferred for advanced regulatory expertise)

Experience:

• 6 to 12 years in Regulatory Affairs
• Strong familiarity with global regulatory guidelines (USFDA, EMA, Health Canada)

H3 – Desired Skills:

• Excellent written and verbal communication
• Self-driven with a proactive approach
• Good interpersonal skills and cross-functional collaboration
• High proficiency in regulatory tools and document management systems

Career Benefits at Dr. Reddy’s

What You Can Expect:

• Competitive salary package
• Support for relocation and joining
• Comprehensive medical insurance for self and dependents
• Professional development opportunities
• Work culture that encourages empathy, growth, and purpose-driven innovation

Relevant Courses That Fit This Role

If you’ve pursued any of the following education programs, you’re eligible to apply:

• M.Pharmacy (Pharmaceutical Chemistry, Pharmaceutics, Regulatory Affairs)
• M.Sc. (Biotechnology, Chemistry, Biochemistry, Microbiology)
• Pharm.D
• PhD in Pharmaceutical Sciences or Life Sciences

 Call to Action

Ready to take the next leap in your Regulatory Affairs career? Join Dr. Reddy’s Laboratories in Hyderabad and contribute to making global healthcare more accessible.

👉 Click here to apply

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