Role Summary: The China RA Manager is an important role that will have significant impact on the realization of GEHCs business aims for China. This position will be responsible for all assigned local regulatory activities in support of the regulatory compliance, new product registration and promotion of GEHC products in China.
Essential Responsibilities: This role will act as the bridge between GEHCs China organization, Commercial, R&D colleagues and other relevant functions so that optimal regulatory activities and development programs are developed and implemented, to ensure rapid regulatory approvals.
• To ensure that local RA activities/projects including supporting new product registration, product lifecycle maintenance (renewal, variations, compliance etc.) and other regulatory activities (documents archive, SOP development etc.) reflect and support the RA department for both local commercial and global business priorities
• To ensure the development and strengthening of relationships with regulatory authorities, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions.
• Partner with GEHC stakeholders to provide proactive regulatory advice and expertise on a local and global basis for Pharmaceutical Diagnostic products.
• To support 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
• To ensure consistent and quality regulatory practices and procedures which are in line with the rest of NRA and meet the needs of global GMS requirement
• To continuously review and put strategies in place to improve existing processes and champion change
Qualifications/Requirements: • Bachelor's Degree in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy
• Minimum 5 years' experience in Regulatory Affairs within the pharmaceutical industry, new products registration experience would be preferred.
• Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
Desired Characteristics: • 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 work independently as required using sound judgment
• 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.
• Willing to travel as needed for key activities.
About Us: GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com Additional Locations: China;BeiJing;Beijing;
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