Johnson & Johnson 职业机会
Director Regulatory Affairs, China_Vision Care
Requisition ID: 1905736536W
The Regulatory Affairs JJV China RA Director reports to the RA Regional Head and is responsible for leading the China Regulatory Affairs teams for JJV. Specifically, this role:
Liases with the franchise regulatory affairs and directs China Regulatory Affairs teams to establish and execute regulatory strategies for new and existing products.
In partnership with JJV RA Leadership, develop and implement China country objectives based on JJV business priorities, and global regulatory strategies and plans in support of JJV regulatory imperatives
Monitors the China regulatory environment and provides assessments of the impact of new and changing regulations on the company's portfolio of products to the Franchise teams.
In partnership with the JJV RA Leadership, ensures aligned and coordinated contact and communication with China Health Authorities.
Enables timely regulatory approvals for key product launches in the China market.
Provides direction and leadership to the regulatory teams in the development and implementation of China regulatory strategies and processes to ensure timely commercialization of new or modified products in compliance with current and appropriate local regulatory expectations.
Provides input for Regulatory Policy shaping and influencing activities with regulatory health authorities on a regional basis.
Ensures appropriate regulatory framework (processes, procedures, etc.) exist to facilitate efficiency and compliance.
Manages, oversees, and balances resource allocation across the JJV China Regulatory Affairs team
Overseeing the development and execution of China regulatory strategies for new and existing (commercialized) product to ensure timely regulatory approvals (30%).
External China environment monitoring and shaping (20%).
Recruiting, hiring, training/onboarding, developing and managing China RA team (20%)
Preparing and managing China RA budget (15%)
Health Authority and Stakeholder interaction/communication (15%)
A Bachelor’s degree with a minimum of 10 years of China Regulatory experience in a regulated healthcare industry (of which a minimum of 2 years within medical device business); OR
Master’s degree, PhD, or PharmD with a minimum of 8 years of China Regulatory experience in a regulated industry is required (of which a minimum of 2 years within medical device business in China).
10-15 years of working experience (see above) in the health industry (could include pharmaceutical, medical device, or associated consumer industries)
Expert knowledge of regulatory activities that achieve regional regulatory approval of medical devices.
Expert knowledge, understanding, and application of principles, concepts and practice of governmental regulations is required.
Sound knowledge of Regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio is required.
Strong organizational, communication, negotiation and interpersonal skills is required.
Ability to effectively negotiate and influence leadership, affiliates, regulatory agencies, and industry to ensure that regulatory requirements and business needs are met is required.
Must be fluent in English and Mandarin both written and verbal