职位描述
Accountability:Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.1. Lead lifecycle maintenance activities for marketed products across TAs.2. Develop regulatory strategy plans to support successful life cycle management (LCM) of established products including line extensions and variations, and provide Regulatory expertise to local product and cross-functional teams.3. Ensure timely Regulatory filings and response to HA queries for marketed products.4. Provide mentoring and coaching to junior staff members.5. Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization.Qualification:1. Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.2. Minimum of 3-5 years regulatory affair experience or relevant in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred.3. Strong oral