Dr Reddys hiring Regulatory Associate – Biosimilar Combination Product

Regulatory Associate – Biosimilar Combination Product at Dr. Reddy’s | Hyderabad | M.Pharm, B.Pharm, BSc Life Sciences | 3–6 Years Experience

Looking to build your regulatory career in biologics and combination products? Dr. Reddy’s Laboratories is hiring a Regulatory Associate for biosimilar combination product development at its Hyderabad location. This full-time, on-premise position is ideal for professionals with 3–6 years of regulatory affairs experience in biosimilars, biologics, or drug-device combinations, and a background in Pharmacy or Life Sciences.

Apply now to become part of a globally recognized pharmaceutical leader committed to innovation, access, and patient safety.

Join Dr. Reddy’s as Regulatory Associate – Biosimilar Combination Product | Hyderabad

Dr. Reddy’s Laboratories, a global pharmaceutical company dedicated to affordable and innovative medicines, is seeking a Regulatory Affairs Professional to support biosimilar drug-device combination products. This role involves driving global regulatory strategies, aligning product development with regional requirements (FDA, EMA, MHRA), and ensuring compliance across the lifecycle.

You will work alongside R&D, Quality, and Clinical teams to shape combination product strategy and ensure successful global submissions.

About Dr. Reddy’s Laboratories

Founded in 1984, Dr. Reddy’s Laboratories has grown into a multinational pharmaceutical leader with over 24,000 employees across 66 countries. Our purpose, Good Health Can’t Wait, drives innovation across biosimilars, active ingredients, and complex generics. Sustainability, diversity, and ethical governance are pillars of our growth as we aim to serve 1.5 billion+ patients by 2030.

We offer equal opportunity employment and foster an inclusive workplace built on merit and purpose.

Key Responsibilities

Regulatory Strategy & Submission

• Develop global regulatory strategies for combination product devices
• Prepare and lead regulatory submissions including IND, BLA, EU MDR dossiers
• Ensure accurate and complete documentation for design controls, risk assessments, and usability
• Interpret regulatory guidelines and translate them into product development actions

Cross-Functional Support

• Partner with R&D, Quality Assurance, Clinical, and Manufacturing teams
• Guide design verification, validation, and Human Factors Engineering (HFE) processes
• Drive post-market surveillance, labeling updates, and lifecycle management

Compliance & Quality Management

• Monitor evolving regulations from FDA, EMA, MHRA
• Maintain documentation aligned with GxP, ISO, and MDR standards
• Participate in audits and CAPA implementations as required

Required Qualifications

• Education:
  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or Medical Sciences
• Experience:
  • 3–6 years in regulatory affairs with a focus on biosimilars, biologics, or combination products
  • In-depth understanding of FDA, EMA, MHRA regulatory environments
  • Familiarity with drug-device combination regulations, risk management, and usability engineering

Work Conditions

• Location: Hyderabad, Telangana, India
• Work Type: Full-time | On-premise
• Business Unit: Biologics | Regulatory Affairs

Call to Action

Apply now via the official Dr. Reddy’s career portal: https://jobs.smartrecruiters.com/DrReddysLaboratoriesLimited/744000063946705-regulatory-associate-biosimilar-combination-product?source=linkedin

Ensure your CV highlights your experience in regulatory affairs for biosimilars and combination products.

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