🎁 Before you apply, rehearse this interview. Create your free WorkMundi account and get an Interview Training on HelpsYouSpeak — no cost, no card. I want my training →
- 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. .