Dr. Reddy’s Laboratories Ltd., a global pharmaceutical leader, is committed to providing affordable and innovative medicines. Established in 1984, the company has grown to include research and development centers, manufacturing facilities, and commercial operations in 66 countries. With over 24,000 employees worldwide, Dr. Reddy’s aims to reach 1.5 billion patients by 2030 through sustainable practices, innovation, and robust corporate governance.
The Biologics division focuses on developing biosimilar products across therapeutic areas, backed by over two decades of experience. The team is known for its high-quality manufacturing, end-to-end capabilities, and global regulatory expertise.
Job Responsibilities
As a Regulatory Affairs Associate, you will be responsible for:
- Dossier Management:
- Drafting, compiling, and finalizing dossiers for regulatory submissions.
- Ensuring adherence to SOPs and archival of documents.
- Regulatory Applications:
- Filing study applications for toxicity, clinical, and marketing authorizations.
- Managing permits and licenses for import/export and commercial use.
- Coordination:
- Liaising with internal teams like Quality Assurance, CMC, and clinical SMEs to compile regulatory information.
- Supporting facility inspections during audits.
- Compliance & Systems:
- Maintaining compliance reports (e.g., PSURs, IBs, APQRs).
- Designing and customizing regulatory information systems like eCTD and DMS.
- Audit Support:
- Coordinating during audits and reporting compliance to regulatory bodies.
Qualifications
- Education: Master’s degree in Life Sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics, Immunology, Regulatory Affairs, Pharmacy).
- Experience:
- Minimum 2 years in regulatory affairs.
- 6 years in biologics/biosimilar R&D is an advantage.
Skills
Technical Skills
- Proficiency with regulatory IT platforms (eCTD, DMS, RIMS).
- Ability to analyze regulatory information for risk assessment.
Behavioral Skills
- Strong negotiation and interpersonal skills.
- Detail-oriented and adept at managing ad-hoc priorities.
- Commitment to continuous learning in regulatory standards.
