Job Description

Job Summary

- Responsible for end-to-end Formulation development including development, execution, filing and approval.
- Assess process feasibility to enable effective product and process knowledge transfer.
- Support selection of suitable manufacturing equipment and establish batch sizes based on plant capabilities.
- Prepare and review master manufacturing records, batch documents, technology transfer packages, development reports, and regulatory filing documentation.
- Execute and support scale-up, exhibit, validation, submission, and commercial batches.
- Ensure availability of equipment, materials, tooling, and supporting resources at the receiving manufacturing site.
- Provide in office and remote technical support during technology transfer, validation, and commercial manufacturing.
- Collaborate with Manufacturing, Quality Assurance, Analytical Development, Regulatory Affairs, Supply Chain, and external partners to ensure successful project execution.
- Prepare investigation reports,



technical assessments, and scientific justifications based on laboratory and manufacturing observations.
- Support manufacturing and Quality teams in implementing process improvements and corrective actions.

Regulatory & Compliance Responsibilities

- Support preparation, review, and compilation of product license applications, regulatory dossiers, and submission packages for global markets.
- Address regulatory queries, deficiency letters, and health authority questions by providing accurate scientific data and technical justifications.
- Ensure the quality, completeness, and compliance of regulatory responses to facilitate timely approvals.
- Prepare and review risk assessments related to:
- Elemental Impurities
- Nitrosamine Risk Assessment and Mitigation
- Residual Solvents
- Product quality, process, and regulatory risks

📌 Formulation Scientist (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad