職位描述
Job Purchase:
Be accountable for the regulatory strategy implementation to obtain the regulatory approval for the designated product group on the registration of New Drug Products, variations of marketed products, license renewals, and global clinical trial applications. Support regulatory strategy development for the responsible projects with the guidance of RA Manager, and independently take charge of the designated projects or the designated registration stages of one project.
Job Responsibilities:
Follow Servier and industry code of conduct and good regulatory practices including Servier RA SOPs and other required SOPs.
Develop regulatory plan in conjunction with key stakeholders, and deliver plans on time.
Prepare the regulatory submissions for registration of new products, variations to marketed products, license renewals within the set timeframe and global clinical trial applications.
Monitor the overall review process and response the additional data request to ensure the set registration strategy and timeline being implemented in a timely manner.
Monitor lab test and ensure Chinese specification in compliance with corporate proposed specification.
Maintain regulatory documentation in line with Servier Procedures.
Provide regulatory support to other sections of the company for related products.
Participate on special projects for the Regulatory Affairs Department.
Keep close communication with internal relevant Departments and HQ, to ensure an effective understanding and implementing of regulatory affairs.
Support RA manager for regulatory intelligence collection and analysis.
Support RA manager on integration for regulatory strategy assessment.
Qualification:
Bachelor degree or above in pharmaceutical, medical or related science.
At least 5 years’ experience in regulatory field.
Good working knowledge of international and local regulatory guidelines and codes
Proficiency in Basic Microsoft Word, PowerPoint and Excel
Fluency (oral and written) in both Chinese and English
