China CDx RA specialist
About the Job
Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements. Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance. Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level. May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
* Works on company regulatory assignments with broadly defined objectives
* Solves straight-forward issues, challenges and problems within area of specialization
We are looking for a highly motivated and experienced Regulatory Affairs professional to join our Agilent team working within the Companion Diagnostics business. This position will be part of the Companion Diagnostics Regulatory Affairs team in China. This person will provide support to ensure proper regulatory submissions, registrations, licenses and approvals in China. The person will work as individual contributor and be based in Agilent Beijing Campus. The person will also need to work efficiently with global R&D, project management team, manufacturing and other functions such as commercial and marketing division.
The preferred candidate would have experience in IVD and be familiar with Companion Diagnostics, and interactions with NMPA. The candidate must have good oral and written communication skills. The candidate will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners.
- Plan and manage the day-to-day NMPA pre-market approval submissions for Companion Diagnostics (CDx) and obtain approval of premarket product registration timely.
- Inform other business units about changing regulations in IVDs and CDx.
- Interact with NMPA on registration requirements and monitor changes to requirements.
- Independently manage and provide regulatory guidance to short-term and long-term projects.
- Proactively manage the changing regulatory environment for company products, prevent barriers to trade, eliminate duplication of effort and identify and mitigate areas of risk.
- Review product labeling and marketing materials for accuracy and compliance with regulations.
- Respond to customers and authorities' requests/inquiries dealing with regulations and product compliance.
- Represent company in external bodies dealing with standards and/or product regulations at the national/global level.
- Work directly with pharmaceutical partners in China.
- Work on company regulatory assignments with clearly defined objectives.
- Solve problems of limited scope and complexity