Job Title: Manager – Regulatory Affairs (US ANDA – Formulations)
Department: Regulatory Affairs
Location: Chennai
Reports To: Director

Job Summary
Responsible for end-to-end regulatory activities related to Abbreviated Recent Drug Applications (ANDAs) for the US market. The role includes dossier preparation, submission, lifecycle management, and direct interaction with the US FDA to ensure timely approvals and compliance.

Key Responsibilities
1. ANDA Dossier Preparation & Submission
Compile, review, and submit ANDAs in CTD/eCTD format in compliance with US FDA requirements.
Author and review key modules (Module 1, 2, 3) including administrative, quality, and labeling documents.
Coordinate bioequivalence (BE) and clinical sections with internal/external stakeholders.
2. Regulatory Strategy (US Market)
Develop regulatory strategies for ANDA filings (Para I–IV certifications, first-to-file opportunities, etc.).
Evaluate Reference Listed Drugs (RLD), Orange Book listings, and exclusivity considerations.




Provide regulatory guidance during product development and pre-submission stages.
3. Lifecycle Management
Manage post-approval submissions including supplements (PAS, CBE-30, CBE-0), annual reports, and amendments.
Handle site transfers, formulation changes, and labeling updates.
Track submission timelines and approval status.
4. US FDA Interaction
Prepare and submit responses to Complete Response Letters (CRLs), Information Requests (IRs), and deficiency letters.
Coordinate cross-functional inputs to ensure timely and high-quality responses.
Support pre-ANDA meetings and other FDA communications.
5. Labeling & Compliance
Review and update US labeling in line with RLD and FDA requirements.
Ensure compliance with US regulations (21 CFR Part 314, ICH guidelines).
Support data integrity and audit readiness.
6. Cross-Functional Collaboration
Work closely with R&D;, Analytical, QA, Manufacturing, and Legal/IP teams.
Align regulatory strategy with product development, patent lan

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