Sr Associate Regulatory Affairs

Compile and submit ANDAs, supplements, annual reports, and labeling supplements in compliance with FDA requirements. Author relevant eCTD sections, ensure proper formatting, and evaluate proposed product and process changes against current guidance. Support regulatory strategy for complex generics and combination products, including transdermal systems and drug-device combinations. Create internal templates and trackers, prepare GDUFA III meeting packages, and coordinate with internal departments and external partners for documentation collection. Lead post-approval changes for site transfers, analytical updates, and material sourcing. Participate in product development from early-stage formulation to final submission, draft product labeling, and review technical documentation for internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design principles.