- 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)
🏢 Biological E
📍 Hyderabad