DUTIES AND RESPONSIBLITIES:
Propose / develop, implement, review and update regulatory affairs strategy. Initiate activities in cope with the long-term and short-term RA strategy. Oversee the progress to ensure product registration operations to be excellent.
- Review product registration strategy and action plan. Timely make recommendations to adjust the strategy to top management team.
- Coordinates with corporate to set up registration plan based on the business needs, ensuring the business compliance with national regulations.
- Familiar with NMPA regulations, process, document review principle and technical requirements. Review registration dossier as internal examiner and guide the project team members to prepare registration documents.
- Prepare regulatory submissions and obtain regulatory permits, including import/export clearance in a timely manner
- Get Corporate RA people understand China RA policy, get aligned and work closely with them.
- Interact with and build rapport with regulatory agencies and notified bodies as required to perform effective and fast track approval of product registrations.
- Monitor the regulation development and regulatory trend in China, report the impact to the company.
- Organize and deliver regulatory education and dissemination of regulation information to the organization.
- Periodically review registration progress and issues with medical staff and other internal groups like marketing, BD, Commercial team.
- Bachelor degree or above in clinical laboratory, health/life science discipline or the equivalent knowledge and experience;
- Minimum 5 years of professional experience in a regulated environment; solid relationship with authority and office;
- Solid knowledge and experience in RA of medical device (pharmaceutical preferred), ISO knowledge is preferred;
- Fluent in English and Microsoft office skills.