Key member of the China leadership team
Provide the highest quality advice on regulatory issues to members of Covance project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to submissions in China - IND, NDA and HGRAC regulations
Evaluate the impact of clinical/regulatory changes on projects as well as Covance business operations.
Manage and oversees the China Regulatory Submission teams ensure preparation of high quality submissions to regulatoryagencies for clinical trial and marketing approval within project timelines in China
Liaise with Regulatory Authorities on behalf of clients.
Provide technical input, advice and recommendations for the creation of registration strategies.
Proactively interact with internal Covance groups and clients to provide regulatory guidance on activities related to the development and registration of new products in China
Coach and mentior director reporst and junior memnrs of the team
Support Business development activties, represent Regulatory Submissions in new proposal opportunities, providing and/or reviewing resource estimates.
Responsible for workload forecasts (resource utilization) for assigned projects and assistance in the preparation of Time and Cost Estimates for Regulatory Submissions projects.
Responsible for line management and resource assignment of junior staff
Proactively maintain awareness of the external regulatory environment by assessing/ monitoring established and evolving regulatory issues and by interacting/observing regulatory authorities at meetings.
Ensure that all reporting staff adhere to professional standards and SOPs established for Regulatory Submissions, as well as applicable Covance directives and requirements.
Work on special regulatory projects as assigned.Education/Qualifications:
Bachelor's Degree in Life Sciences or equivalent, possibly with a higher qualification.
♦ Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations in particular.
Minimum of 8 years experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development
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