The Senior International Regulatory Affairs Specialist will prepare regulatory submissions and interact with health authorities/agencies to obtain and maintain product approvals in China and in other countries as applicable. Recommend strategies to enable approvals of clinical trials applications. Participate in international regulatory intelligence groups and represent Regulatory Affairs on the product lifecycle management teams as appropriate.
* Prepare and maintain regulatory submission files for China and ROW.
* Deliver documentation for registration of Cepheid products to health agencies.
* Partner with global and regional marketing in the development of regulatory plans.
* Interact with global regulatory leaders to expedite approvals of any pending registrations.
* Establish and review Regulatory Affairs priorities as they relate to department, company goals, and objectives.
* Manage and monitor multiple complex, novel, and/or diverse regulatory projects simultaneously including projects that involve several functional areas.
* Oversee clinical trials and government lab testing in China.
* Maintain a "focused urgency" as required by specific events through the identification and utilization of the most effective business practice to execute against project objectives.
* Suggest significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.
* Identify potential regulatory risks to plan including situations that include ambiguity by proactively reviewing and analyzing internal/external factors to mitigate risks.
* Formulate short-term planning for individual deliverables and participate in long term planning within the department/group.
* Act as a regulatory representative to product development and cross-functional teams by providing regulatory training and/or guidance.
* Assume routine and non-routine contact with health agencies including the preparation of responses to regulatory agencies’ questions and other correspondence.
* Maintain knowledge on current development in the fields of regulatory and industry trends.
* Bachelor’s degree in a scientific discipline or related field is preferred. Or, equivalent combination of education and experience to perform at this level.
* A minimum of 8 years experience in a fast-paced regulatory/compliance/quality team at an in vitro diagnostic (IVD) or medical device manufacturing site.
* Thorough knowledge of regulatory requirements for the registration of new products.
* Strong communication skills (oral, written, and presentation) to effectively communicate technical and non-technical information.
* Able to work cross-functionally with a diverse team.
* Self-directed and able to handle ambiguous issues while providing appropriate input towards suitable actions.
* Excellent PowerPoint, Excel, and Word knowledge.
* Able to travel up to 20% internationally.