Johnson & Johnson Careers
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Manager, Regulatory Affairs
Requisition ID: 1805641414W
Be responsible for the registration activities of J&J consumer drug and relevant regulatory affairs support. Lead relevant RA subgroup to obtain new product registration approval. Provide regulatory support to Business.
• Provide innovative regulatory strategies/ direction to the business for relevant consum-er drug products.
• Connect with global and regional colleagues to develop regulatory strategy and path-way to speed up products to market in China, and support in market products to en-sure compliance.
• Work with global/ regional/ local colleagues to identify core processes and support re-quired to ensure projects can be aggressively implemented in China with greatest commercial impact.
• Lead relevant RA subgroup and take care of people development for regulatory team.
• Involve in external engagement, sitting as key company representative in several indus-try associations to deliver JnJ voice and drive china regulatory reform.
• Organize key external projects with authorities and associations to build JnJ high pro-fessional image and credibility on technical/regulatory issues.
Education level requirement:
Bachelor or above, Chemical/ Pharmaceutical/biological background is preferred.
• At least 5 years working experience in pharmaceu-tical product registration especially in new drug/creative drug registration, familiar with CFDA registration requirements.
• MNCs and OTC registration experience is pre-ferred.
• Fluent IT skills on Microsoft office, Outlook and in-ternet operation.
• Sufficient in English reading and writing.
Shanghai Johnson & Johnson Pharmaceuticals, Ltd. (7048)