Main Purpose
This position is responsible to lead RA team, oversee and ensure all activities related to product registrations and renewals, and change notifications are executed in alignment with the business needs and in a compliant manner for China for both imported and locally produced products plus manufacturing process certification.
Duties and Responsibilities
Strategy Development
- Develop China regulatory strategies in alignment with global strategy for new products
- Ensure close collaboration with the Global Regulatory Product Owners and other stakeholders in China so that regulatory aspects of the assigned product family are managed efficiently and effectively during the lifecycle of the product
- Provide regulatory inputs to the China submission plan to ensure that the plans are up to date, ensure compliance to regulations, and meet the needs of the business
Stakeholder engagement / market intelligence monitoring
- Directly communicate with local authorities (Testing Lab, CMDE and NMPA) upon implementing regulatory strategies on submissions.
- Represents HSO and participate in industry association's forums to establish networks and look for opportunities to shape regulatory framework in alignment with the company's policy direction and business objectives.
- Maintain oversight of the changing regulatory environment in China, identify the risks, and execute plan to overcome the risks
People Management
- Management of direct reports, accurate budgeting, objective settings, performance reviews, coaching and development
- Coach team to prepare submissions for product registration, amendment, renewals with or without help of consultants, and coordinate responses to address queries.
Project Management
- Act as the RA liaison regarding local type testing, registration and regulatory compliance with local authorities/testing labs, HOYA China team, HOYA regional teams where applicable.
- Lead in local, regional and global level projects where regulatory inputs for China are required.
- Be accountable for timely approval of new product submissions, change notifications, license renewal/s to China regulatory authorities and addressing questions and observations related to the process.
Requirements
Experience
- Minimum 12 years in IOL or Class III device experience preferred. Have gained class III approvals, imported products and/or domestic products. Proven track record in leading RA team
- Experience in locally produced product registration as well as imported products registration plus manufacturing process certification.
- Expert knowledge of China regulatory process and regulations
- Interaction and advocacy with NMPA and testing labs
- Knowledge and ability to do hands on submission and product renewals
Skills/Accreditations
- Demonstrated leadership and project management skills to handle complexity and ambiguity in a dynamic fast-paced environment, including stakeholder influencing and stakeholder engagement, cross-functional collaboration, effective communication.
- Must have strong analytical and critical thinking to evaluate complex ambiguous situations, identify potential issues and future trends.
- Demonstrated problem solving skills applied to regulatory topics such as application rejection, issue management, supply disruption and guiding China RA team in health authorities' interaction.
- Fluent in English (verbal and written) and Mandarin with ability to communicate effectively, present and discuss (complex) technical information to regional stakeholders / global stakeholders confidently.
Academic Qualifications
- Bachelor's degree in science (Pharmaceutical Science) or related degree in Science, Engineering, Biotechnology, or equivalent technical experience.