Regulatory Affairs Associate (Biologics) at Dr. Reddy’s Laboratories in Hyderabad
A rare chance has emerged for experienced professionals in the field of regulatory affairs. Dr Reddy’s careers include this Regulatory Affairs Associate (Biologics) opening at Dr. Reddy’s Laboratories in Hyderabad. This role requires 3–5 years of experience in Biologics Regulatory Affairs, making it an excellent opportunity for qualified candidates to advance their careers.
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories is a global pharmaceutical company headquartered in Hyderabad, India. The organization is engaged in the development and manufacturing of a wide range of pharmaceutical products, including generics, biosimilars, and proprietary medicines. With a commitment to improving access to affordable healthcare, Dr. Reddy’s operates in various therapeutic areas and is known for its innovation in drug development.
Job Details:
Company: Dr. Reddy’s Laboratories Ltd.
Location: Hyderabad, Telangana, India
Experience: 3–5 years in Biologics Regulatory Affairs
Qualification: Master’s in life sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, Regulatory Affairs, Pharmacy, etc.)
Posted On: 28 August 2026
Application Deadline: Not specified
Dr Reddy’s Careers: Job Description
Within Dr Reddy’s careers, the Regulatory Affairs Associate will be responsible for preparing and compiling regulatory documentation, including dossiers and submissions. The role involves analyzing and interpreting regulatory guidelines, ensuring compliance, supporting regulatory applications, conducting regulatory research, and collaborating with cross-functional teams to gather necessary information for submissions. Additionally, the associate will monitor changes in regulatory requirements and support the organization’s compliance program through documentation and reporting.
Key Responsibilities
- Prepare and compile regulatory documentation, including dossiers and submissions.
- Analyze and interpret regulatory guidelines and industry standards.
- Support the preparation and submission of regulatory applications.
- Conduct regulatory research and gap analysis.
- Collaborate with cross-functional teams to gather necessary information.
- Monitor changes in regulatory requirements and communicate updates.
- Support the organization’s regulatory compliance program.
- Manage regulatory life cycle documentation.
Eligibility for Dr. Reddy’s Laboratories Careers
- A Master’s degree in any of the life sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, Regulatory Affairs, Pharmacy, etc.).
- 3–5 years of experience in Biologics Regulatory Affairs.
- Additional experience in biologics/biosimilar R&D, process, or analytical development is advantageous.
Required Skills
- Good understanding of IT platforms supporting regulatory activities, including eCTD publishing and Regulatory Information Management Systems (RIMS).
- Ability to analyze regulatory information to identify risks.
- Excellent verbal, written, communication, and interpersonal skills.
- Strong logical and analytical attributes.
- Good understanding of CMC, NC, and Clinical aspects of a Regulatory dossier.
- Sound knowledge of ICH/LATAM guidelines on submission requirements.
- Understanding of global regulatory affairs.
How to Apply
Interested candidates can apply for the position through the official link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE.
Conclusion
This Dr. Reddy’s Laboratories careers opportunity offers qualified candidates an exciting chance to contribute to regulatory affairs within a leading pharmaceutical company. Therefore, interested individuals are encouraged to apply at the earliest to seize this opportunity.
