500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
Directs the development of submission of product registration, progress reports,supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.Interacts and negotiates with regulatory agency personnel 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. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission. * Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions. * Provides input into global regulatory strategy and contributes to Regulatory Functional * Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions. * Partners with regions to align on regulatory strategy in order to fulfil business objectives * Implements RFP across assigned regions. * Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL. * Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. * Develops and implements plans for timely response to HA requests and coordinates responses. * May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL. * Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL. * Contributes to and often leads the development of departmental goals and objectives.