The position involves directing the development and submission of product registration, progress reports, supplements, amendments, and periodic experience reports. The role provides strategic product direction to teams on interactions and negotiations with regulatory agencies, ensuring rapid and timely approval of new drugs, biologics/biotechnology, and medical devices. The individual will serve as a regulatory liaison throughout the product lifecycle, interacting with regulatory agency personnel to expedite approvals and address inquiries. Responsibilities include implementing regulatory strategy, managing operational activities for assigned regions, and contributing to global regulatory strategy. The role also involves reviewing and submitting Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and facilitating timely responses to Health Authority (HA) requests.