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Role Summary: An important and highly visible role that will have significant impact on the realization of GEHCs business aims for China. Responsible for effective regulation influencing and innovative regulatory strategies in a challenging regulatory environment. This role will act as the bridge between GEHCs China organization, Commercial and R&D colleagues so that optimal regulatory strategies and development programs are developed and implemented, to ensure rapid regulatory approvals.
Essential Responsibilities: • To ensure that China proactively influences the Chinese regulatory environment, develops effective regulatory strategies and operational plans for new product registrations that meet business goals in an effective, timely and compliant manner. • Develop and strengthen relationships with Chinese Regulatory agencies –CFDA, CDE, CFDI, NIFDC, Ch.P. etc. • Drive the implementation of regulatory strategy and plans aligned with business goals in China • Partner with GEHC stakeholders to provide proactive regulatory advice and expertise on a global basis for core imaging products. • Ensure effective dialogue between China RA and wider GEHC to ensure clarity of understanding and determine the most effective path to optimal regulatory approval • Ensure effective Regulatory Intelligence gathering, interpretation and dissemination to Global RA and R&D Colleagues to inform current and future China regulatory strategy and consequent impact on R&D support required • Be a core project team member on any R&D program developing new diagnostic products for China; work closely with the other core team members of project team • To ensure consistent and quality regulatory practices and compliance for core imaging products in China and that all Regulatory Affairs activities reflect both local commercial and global business priorities
Qualifications/Requirements: • Advanced degree in a Science discipline. • Minimum 10 years’ experience in Regulatory Affairs within the pharmaceutical industry with minimum of 3 years new products registration experience. A considerable amount of this experience should have been gained in a senior role in the area relevant to their position
Desired Characteristics: • Demonstrated experience designing and implementing regulatory product strategy, interfacing with local and/or corresponding international regulatory bodies, including negotiation of pharmaceutical product approvals & lifecycle maintenance, resolution of issues and influencing/lobbying directly and through other external groups (e.g. trade associations) • Demonstrated understanding of the healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies in China would be highly desirable. • Demonstrated experience operating in a highly regulated environment. Proven application of analytical skills in a regulatory environment • Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English & Chinese, tailoring communication methods to customer’s requirements. • Ability to influence at all levels of the company • Ability to work independently as required using sound judgment • Demonstrated ability to form, lead and manage cross-functional, cross-business teams. • Demonstrated project management skills and the ability to prioritize, plan & evaluate deliverables to established strategic goals. • Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research. • Must be willing to travel as needed for key activities.
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