5++

Define and execute the discovery biology strategy across modalities small molecules, antibody, ADC, and cell & gene therapy in alignment with company goals.

Develop and execute quality and compliance monitoring activities for PS processes within area of expertise to support a robust GVP Quality Management System.

Participation in Trade Association calls in listening & learning, observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.

This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes.

To ensure the compliance of internal/ external audit and to ensure timely adequate response of audit finding from the department to the auditor to close the issue.

Lead Regulatory strategy and implementation for assigned TA and oversight of execution of strategy, timely submission, query responses, SEC meetings.

Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.

Lead preparation, review, and control of SOPs, master documents, protocols, and reports for the packaging department.

To ensure quality compliance as per regulatory requirements in manufacturing operations and quality function at site.