Regulatory Affairs Specialist at Dr. Reddy’s

Published on

September 7, 2025

Regulatory Affairs Specialist

Dr. Reddy’s

Master’s degree in Pharmacy, Biotechnology, Microbiology, Biochemistry, Immunology, Bioinformatics, or Regulatory Affairs.

Andhra Pradesh

2 years

Verified Job

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Dr. Reddy’s Laboratories, a global leader in pharmaceuticals, is hiring a Regulatory Affairs Specialist in Andhra Pradesh, India. This role is ideal for life sciences and pharmacy professionals with regulatory experience, offering a chance to work in the biologics and biosimilars segment, one of the fastest-growing areas in the pharmaceutical industry. If you are detail-oriented, passionate about compliance, and want to grow with a leading MNC, this is the role for you.

📌 Job Responsibilities

As a Regulatory Affairs Specialist, you will:

Finalize, draft, compile, and archive regulatory dossiers while adhering to SOPs.
File regulatory applications (toxicity, clinical, marketing authorizations) and manage query responses.
Liaise with internal stakeholders (CMC, Non-Clinical, Clinical SMEs) for regulatory data.
Coordinate with QA teams during audits and support regulatory compliance during inspections.
Execute IBSC activities, ensure compliance with the Ministry of Science & Technology.
Draft SOPs for regulatory processes, manage post-approval changes (PACs), APQRs, PSURs, PILs, IBs, and compensation reports.
Maintain regulatory systems including eCTD, SharePoint, and Document Management Systems (DMS).

🎓 Qualifications

Education: Master’s degree in Pharmacy, Biotechnology, Microbiology, Biochemistry, Immunology, Bioinformatics, or Regulatory Affairs.
Experience: Minimum 2 years in regulatory affairs (biologics/biosimilars experience preferred).
Technical Skills: Knowledge of eCTD, RIMS, DMS, regulatory compliance systems, and risk analysis.
Soft Skills: Negotiation, cultural sensitivity, detail orientation, adaptability, and strong interpersonal communication.