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.
💼 Benefits at Dr. Reddy’s
- Competitive salary and perks aligned with industry standards.
- Relocation and joining support.
- Family-friendly benefits including maternity and paternity leave.
- Comprehensive medical and life insurance coverage.
- Continuous learning & professional development programs.
- Exposure to cutting-edge biosimilar development and regulatory systems.
📝 Application Process
