Role & responsibilities
Prepare, compile and review regulatory documentation for USFDA submissions related to injectable products.
Support preparation and submission of ANDA dossiers in CTD/eCTD format.
Coordinate compilation and review of CMC/Quality sections Modules 2 and 3.
Review technical documents related to drug product, API, formulation, manufacturing process, analytical methods, specifications, validation and stability.
Support preparation of responses to USFDA deficiency letters, Information Requests (IRs), Complete Response Letters (CRLs) and other regulatory queries.
Coordinate with internal departments for timely collection and completion of regulatory documents.
Support preparation of ANDA amendments, supplements and post-approval submissions.
Assist in regulatory assessment of manufacturing process changes, analytical changes, formulation changes, packaging changes and site-related changes.
Maintain regulatory trackers for submissions, queries, commitments, approvals and post-approval activities.




Support preparation/review of drug product labels and labeling documents as applicable.
Coordinate with CMC, R&D;, QA, QC, Production, Engineering, Packaging and other stakeholders for regulatory submissions.
Review documents for regulatory compliance, consistency and completeness before submission.
Support eCTD publishing and submission activities and ensure documents meet applicable submission requirements.
Maintain regulatory databases and product-wise submission records.
Monitor applicable USFDA regulations, guidance documents and regulatory updates impacting injectable products.
Support preparation of regulatory intelligence and product-specific regulatory requirements.
Ensure timely completion of assigned regulatory activities in line with project timelines.

Preferred candidate profile
25 years of experience in US Regulatory Affairs.
Candidates with specific experience in injectable/parenteral formulations will be p

📌 Walk In Regulatory Affairs Executive Ahmedabad
🏢 Immacule Life Sciences
📍 Ahmedabad