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Role Summary: • The China/APAC Associate Director of Regulatory Affairs for Cell Therapy business is an important and highly visible role that will have significant impact on the realization of GEHCs business aims for China and APAC
Essential Responsibilities: • This role will act as the bridge between GEHCs greater China/APAC organization, Commercial and global cross functions so that optimal regulatory strategies and programs are developed and implemented, to ensure rapid regulatory approvals and to shape better regulatory environment of cell therapy To ensure that China/APAC proactively influences the China/APAC regulatory environment, develops effective regulatory strategies and operational plans for new medical device registrations/life cycle maintenance that meet business goals in an effective, timely and compliant manner. • Develop and strengthen relationships with Chinese Regulatory agencies –CFDA, CMDE, CDE, CFDI, NIFDC. etc. • Focused Regulatory strategy support for Cell Therapy portfolio • Responsible for effective regulation influencing and drive regulatory strategies & plans aligned with business goals in a challenging regulatory environment • Delivers operational plans for new product registrations that meet business goals in an effective, timely and compliant manner. • Partner with GEHC stakeholders to provide proactive regulatory advice and expertise on a global basis for cell therapy products. • Ensure effective Regulatory Intelligence gathering, interpretation and dissemination to Global RA, commercial team and global R&D Colleagues to inform current and future regulatory strategy • 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 and /or Medical Device registration. A considerable amount of this experience should have been gained in a senior role in the area relevant to the position
Desired Characteristics: • Demonstrated experience designing and implementing regulatory product strategy, interfacing with local and/or corresponding international regulatory bodies, including negotiation of medical device 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 and/or AP region 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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