Walk-in || Regulatory Affairs Executive

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 preferred.
• Experience in ANDA preparation, CMC documentation and eCTD submissions is highly desirable.
• Exposure to USFDA deficiency responses and post-approval regulatory activities will be an advantage.
• Candidates currently working in USFDA-approved pharmaceutical manufacturing facilities will be preferred.
• Strong attention to detail and ability to manage multiple regulatory activities within defined timelines.