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.
Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.
Ipca is a fully integrated, rapidly growing Indian pharmaceutical company with a strong thrust on export. Ipca'a API and Formulation produced at world class manufacturing facilities are approved by leading drug regulatory authorised including the USFDA.
Post : Manager - Quality Assurance (QMS & Documentation Lead)