Reg Affairs & Quality Assurance Associate Director at Alcon - A Novartis Division

Directs the development of submission of product/process registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence requirements with regulatory agencies. Interacts and negotiates with regulatory agency in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Participates in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC). Ensures rapid and timely approval and continued approval of products. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission. Keeps abreast of all applicable rules, regulations, guidance documents, and interfaces with industry associations. May coordinate and maintain reporting schedules for new and marketed product notices.