Packaging Development - Topical and Nasal

As an R&D Executive at PTC - MORAIYA, your primary responsibility will be characterizing materials and developing/qualifying packaging systems including primary, secondary, and tertiary packaging. You will be tasked with completing design control deliverables and ensuring compliance with relevant regulatory requirements for submission. Additionally, you will provide post-launch troubleshooting support for complex products and develop various drug delivery devices such as Pen Devices, Auto Injectors, DPI, and pMDI while maintaining a deep understanding of regulatory expectations. Your role will involve compiling essential documents such as User Requirement Specifications (URS) and design control/history files for combination products. You will be responsible for conducting functional performance studies of devices, coordinating with vendors to execute non-disclosure agreements, and finalizing trade dress. Furthermore, you will source new packaging materials, develop new vendors, track packaging material availability and procurement, and support cost evaluation processes. In this position, you will prepare lab notebooks, Packaging Development Reports, Bill of Materials (BOMs), and batch Packaging Records for various stages from engineering batches to commercial batches. You will also be involved in preparing specifications, standard test procedures for packaging material components, Standard Operating Procedures (SOPs), and guidelines. Troubleshooting issues related to the process and usage of packaging materials, conducting SAP-related activities, managing change control procedures, and responding to packaging-related queries from regulatory authorities will be part of your responsibilities. Moreover, you will design pack configurations for commercial launch based on marketing requirements, conduct transportation studies, revise artworks for Reference Listed Drug (RLD) changes, and optimize pack configurations to meet marketing needs, cost considerations, and automation requirements. Your role will require attention to detail, regulatory compliance, and effective communication with internal and external stakeholders to ensure the successful development and implementation of packaging systems.,