Regulatory Specialist
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Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
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
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
IC
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
