Regulatory Affairs Associate

该职位来源于猎聘 The responsibilities of Regulatory Affairs and Strategy (RAS) Department is to support the biotech and pharmaceutical companies on facilitating the development processes to the market with regulatory compliance for any of Pharmaceutical Products. All of the services/applications related to the Health Authorities (Clinical trials and their life cycle management throughout market authorization application/product license life cycle management) will be prepared and facilitated by RAS department, including but not limited to the Regulatory Documents Authoring, preparation and relevant consultation and etc. There are With average of 15-year global development experiences for different types of products and services from Department Managements, we are continuously supporting the team to grow together with our company and the career’s success of each member.

Responsible for project administration with guidance. Responsible for eCTD preparation, filing and publishing with guidance. Responsible for paper files preparation and submission with guidance. Responsible Country Regulatory Submission for Clinical Study and life cycle with guidance. Responsible Country Regulatory Submission for Market Approval and life cycle with guidance. Support Country Regulatory Consultation and Strategy with guidance. Support CTD writing with guidance. Support Package Review and Gap analysis with guidance. Support Project Leadership, Coordination and Strategy with guidance. Responsible Regulatory Intelligence with guidance.