Pharm'Up 
Dr. Reddy’s Laboratories has announced a recruitment opportunity for a Regulatory Affairs Associate (Fixed Term Contract / External Manufacturing) [cite: intended for maternity leave coverage, based in Hyderabad]. The role focuses on supporting North American and global generic/biologics operations by managing core regulatory submissions, compliance, and lifecycle management activities.
Key Responsibilities
- Regulatory Submissions: Authoring, compilation, and publishing of regulatory submissions including CMC (Chemistry, Manufacturing, and Controls) supplements, NDAs, and ANDAs.
- Lifecycle Management: Independently supporting lifecycle management activities for external and in-licensed products, ensuring regulatory compliance.
- Operational Support: Coordinating with Contract Manufacturing Organizations (CMOs), managing change controls, maintaining FDA communication files, and handling GDUFA-related submissions.
- Documentation & Strategy: Preparing regulatory strategy notes, reviewing master documents, and supporting cross-functional teams and product launches.
Candidate Profile & Requirements
- Educational Qualifications: Bachelor’s or Master’s degree in any life science discipline (such as Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, or Pharmacy). Regulatory Affairs Certification (RAC) is highly desired.
- Work Experience: 3 to 6 years of generic pharmaceutical or biologics regulatory affairs experience.
- Technical Skills:
- Hands-on experience with CMC submissions, dossier preparation, and labeling activities.
- Sound understanding of US 21 CFR regulations, ICH guidelines, and global submission requirements.
- Familiarity with eCTD publishing and regulatory information management systems.
Additional Information
- Experience Required: 3–6 years
- Location: Hyderabad, Telangana
- Application Deadline: 30th October 2026
About the Author
