Director, Regulatory Affairs

Leads global regulatory strategies and guides cross-functional teams to assure drug products and devices are developed in line with the applicable regulatory requirements of targeted countries and obtains license approvals (e.g., IND, NDA, ANDA, 510k) and registrations or authorizations for these products to bring safe, approved medicines and devices to market. Maintains registrations of existing drug products and devices in compliance with applicable regulations. Prepares and submits post approval reports as required by the US regulations and other regulatory agencies where the product is licensed. Represents the company in all Regulatory interactions with Health Regulatory Authorities in the US and worldwide, as applicable.