Associate Director/Director Regulatory Affairs - China/Japan Liaison

Regulatory Professionals
East Horsley
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Associate Director/Director Regulatory Affairs - China/Japan Liaison Location: Cambridge Salary: Excellent base salary and flexible benefits Regulatory Professionals are working with a well-established and respected pharmaceutical company who are looking for an Associate Director or Director to liaise with their Chinese and Japanese Regulatory agencies. The company provide strategic support to pharma and biotech companies on a global scale and has a network stretching across over 50 companies worldwide. Main Responsibilities: * Validate strategy and planning for IND and NDA Applications for CFDA/ PMDA submissions * Establish regular meetings (by teleconference, videoconference and face to face) with China/Japan Regulatory Affairs to build relationships and identify any problems or new requirements. * Develop best practices for the company's research and development to assist in agency interactions * Work closely with China/Japan Regulatory Affairs and Regulatory Leads to develop best practices * Actively network in the regulatory field to identify and improve ways of working * Advise Regulatory Affairs Leads and Regulatory Operations of dossier and submission requirements for China/ Japan * Participate in project teams, provide strategic guidance for research and marketed products * Where necessary, lead complex interdisciplinary project teams, as well as assisting with team development and supporting the senior management team. Application Requirements: * Science degree or equivalent qualification or equivalent industry experience. * Ability to communicate in Chinese and/or Japanese is essential * Breadth of technical regulatory knowledge and experience of working with Chinese and Japanese regulatory submissions * Ability to negotiate and influence internal and external bodies * Proven experience of responsibility and accountability for managing and delivering regulatory projects * Strategic thinking and capability of building effective working relationships Skills such as strategic thinking, exceptional verbal and written communication ability, a positive attitude and effective time management are also greatly valued in addition to the above. Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you'll receive £250 worth of vouchers of your choice. Japan, China, strategy, advice, regulatory, Cambridgeshire, submissions, CFDA, PMDA