Prepare, review, and coordinate regulatory submissions, including: 1)Biologics License Applications (BLA)/Biosimilar 2)Marketing Authorization Applications (MAA) 3)Investigational Recent Drug (IND) applications 4)Investigational Medicinal Product Dossiers (IMPD) 5)Post-approval supplements, variations, and amendments
Author and review CMC documentation for Drug Substance (DS) and Drug Product (DP).
Coordinate with cross-functional teams, including CMC Development, Manufacturing, Quality Assurance, Quality Control, Analytical Development, Clinical, Pharmacovigilance, and Project Management, to compile high-quality regulatory submissions.
Prepare responses to Health Authority queries, including Information Requests (IR), D120/D180 assessment reports, deficiency letters, and clarification requests.
Support lifecycle management activities, including product variations, supplements, renewals, annual reports, and change control assessments.




Assess manufacturing, analytical, and process changes for regulatory impact and recommend appropriate submission strategies.
Support eCTD dossier compilation, publishing, validation, and submission activities.
Ensure regulatory documentation complies with regional regulatory requirements, ICH guidelines, and company procedures.
Prepare scientific advice meeting packages and support interactions with global health authorities.
Review source documents for data accuracy, consistency, and regulatory compliance.
Support facility registration, SPL submissions, drug listing activities, and maintenance of regulatory databases.
Track submission timelines and ensure timely execution of regulatory deliverables.

📌 Regulatory Affairs Executive & Senior Executive Hyderabad (India)
🏢 Biological E
📍 India