Regulatory Affairs Director
GE HEALTHCARE · Beijing, Beijing, China
Posted 4 days ago
About this role
<h1><b><b><b>Job Description Summary</b></b></b></h1>Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.<br><br>GE HealthCare is a leading global medical technology and digital solutions innovator
Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><b>Job Description</b></h1><p><b>Primary Responsibilities: </b></p><ul><li>Develop regulatory strategies for innovative drugs in China, including the submission of IND (Investigational New Drug) and NDA (New Drug Application). </li><li>Work closely with healthcare regulatory bodies in China to ensure compliance with premarket and post-market regulatory requirements
</li><li>Develop relationships with Chinese Regulatory agencies (NMPA, CDE, NIFDC, Ch.P. etc.) and responsible for communication with regulatory authorities regarding new drugs, including Pre-IND, End of Phase II/Phase III, and Pre-NDA meetings.</li><li>Utilize in-depth regulatory knowledge and analytical thinking to execute policies and strategies. </li><li>Lead a small team, mentor colleagues with less experience, and drive consensus within the team on relevant topics
</li><li>Stay informed about new policies and requirements, and assess their impact on business and regulatory strategies, insure to follow company processes and quality management
Apply for this role on GE HEALTHCARE’s official careers site.