Team Leader (Regulated Markets 7 to 10 Years of experience)
Regulatory Affairs with robust experience in Global markets (US, EU & ROW) demonstrating solid understanding of current regulations and guidance. The role involves handling DMF/CEP submissions, deficiency management, post-approval changes and lifecycle management activities in compliance with global regulatory requirements.
Candidates should be having a combine experience of API & FDF.
Key Responsibilities: 1. Regulatory Submissions (Initial Filings & Deficiency management):
Preparation, compilation, and submission of DMF/CEP/ASMF per global requirements
Providing submissions are compliant with CTD/eCTD formats
Coordinate with cross-functional teams (R&D;, QA, QC, Manufacturing) for DMF planning and on time filing
Manage and respond to deficiencies within the stipulated timeline and ensure there are no repeat deficiencies
Post-Approval Variations & Lifecycle Management:
Assess and provide filing strategies for post approval changes, and ensure timely filings
Manage amendments & annual report filings
Track submission timelines and approvals
Regulatory Compliance & Strategy:
Ensure compliance with regional regulatory guidelines and requirements
Interpret evolving regulatory requirements and implement changes
Support regulatory strategy for lifecycle management
Documentation & Regulatory Operations:
Maintain regulatory trackers, databases, and archives
Perform technical review for completeness and compliance
Handle deficiency responses and queries from regulatory authorities