Regulatory Affairs Manager
5 years Experience : posted 3 years ago in Maidenhead , in UK Email JobJob Description
• Responsible for driving development and implementation of regulatory strategy for China for development products and new product registrations.
• Member of regulatory project team(s) representing the China for 1-3 development/marketed products.
• Work with global clinical development and R&D teams to prepare regulatory documentation to support regulatory engagement (pre-IND/pre-NDA) and
NDA submissions in China, in particular briefing books and Module 2 documentation.
• Attend global regulatory, cross-functional R&D and asset level business meetings to provide strategic direction and scientific rationale for regulatory
activities required to support clinical trials and marketing applications in China.
• Provide oversight of local operational activities required to make regulatory applications in China, via CRO and company affiliate. Steer preparation and review of submission dossier.
• Maintain close collaboration and partnership with China/regional business colleagues, up to and including President of APAC, in addition to local medical and clinical operations colleagues.