Regulatory Specialist

Your Opportunity

You will be filling the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner.

You will make sure the accuracy and truthfulness of the registration dossiers. Maintain the registration and approved dossiers per company requirements.

You will be per company requirements, cross check for the registration dossier to make sure the accuracy and truthfulness of the registration dossiers.

You will establish and maintain the good and closed relationship with NMPA testing centers. And successfully gains product QC testing reports per registration forecast plan.

You will close working together with CO and CCOE team to provide the regulatory supports on time.

You will provide the cross cooperation with other departments

You will establish and maintain the good relationship with key contacts. Recommend valuable suggestion to company.

Who you are

You hold bachelor degree or above, relevant subject on medicine/bioengineering/clinical medicine/ biochemistry or pharmacy.

You have not less than 2 years’ experience in medical regulatory affairs, focusing on testing center and clinical trial, and familiar with NMPA Standards and guidelines.

You are familiar with relevant NMPA registration regulation and policies.

You are familiar with English communication at the workplace

You are good skill on computer, MS-Office operation.

You are willing to work under pressure, self-starting and self-inspiring