Regulatory Specialist

Job description

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. The PositionA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 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 Who we areA healthier future drives us to innovate. Together, more than 100’000 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. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.