Responsible for providing support to regulatory managers and others for the timely submission of information to Regulatory Authorities in support of investigational and marketed products in China, including China IND, PDA fiiling, Import/export permit applications and HGRAC submissions
Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Covance groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements.
Preparation of documents to the required standard and to maintain awareness of
current regulatory standards related to regulatory submissions for drug and biologic products.
May be involve in line management, mentoring and proding guoidance to junior staffs
Bachelor’s Degree in Life Sciences or equivalentExperience:
2 years of experience in the Pharmaceutical industry, preferably in Regulatory Affairs or Drug
Experience with China IND or China HGRAC submissions is preferred