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

2.



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

3. Regulatory Compliance & Strategy:

- Ensure compliance with regional regulatory guidelines and requirements
- Interpret evolving regulatory requirements and implement changes
- Support regulatory strategy for lifecycle management

4. Documentation & Regulatory Operations:

- Maintain regulatory trackers, databases, and archives
- Perform technical review for completeness and compliance
- Handle deficiency responses and queries from regulatory authorities

📌 Regulatory Affairs-Team Leader (Vadodara)
🏢 Brooks Steriscience
📍 Vadodara