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