Job
Description
Role & responsibilities: Prepare, review, and compile ANDA submissions in eCTD format, ensuring high-quality, complete, and compliant dossiers with minimum supervision. Review and finalize Module 1, 2, and 3 documents, including CMC sections, in coordination with R&D, QC, and QA. Draft and update product labeling (PI, carton, container, SPL) in accordance with FDA requirements and internal templates. Support pre- and post-submission activities, including preparation of amendments, annual reports, controlled correspondences, and supplements (CBE-0, CBE-30, PAS). Collaborate with cross-functional teams to gather required documentation and data to meet submission timelines. Participate in the preparation of responses to FDA deficiencies/CRLs, ensuring scientific justification and regulatory compliance. Maintain up-to-date knowledge of US FDA regulations, guidance documents, and industry trends affecting sterile and complex generics. Maintain submission tracking systems and regulatory archives for assigned products. Preferred candidate profile: 5 - 10 years of relevant experience in US Regulatory Affairs with a focus on sterile dosage forms (injectables, peptides, microspheres, BFS, nasal sprays, ophthalmics, ointments). Strong working knowledge of ANDA submission structure, eCTD publishing tools, and regulatory systems. Hands-on experience in drafting or reviewing CMC documentation (Module 3) and labeling components. Experience in working with multidisciplinary teams to manage submission deliverables. Familiarity with FDA communications, controlled correspondences, and post-approval reporting requirements. Excellent organizational, documentation, and communication skills. Interested candidates can share your updated cv to talent@difgen.com
