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Job Summary
Assist to prepare, submit the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner.
Make sure the accuracy and truthfulness of the registration dossiers. Maintain the registration and approved dossiers per company requirements.
Assist QC testing per registration forecast plan.
Support the regulatory affair related work, including but not limited to payment, reagent order, achieving document management, warehouse management, etc.
Provide the cross cooperation with other departments.
Establish and maintain the good relationship with key contacts. Recommend valuable suggestion to company.
Main Tasks & Responsibilities
Assist to prepare the registration dossier to NMPA and obtain the approval to meet the registration plan.
make sure the accuracy and truthfulness of the registration dossiers and maintain all the submission and approved dossiers in related IT systems, share points, V drive, and notify all the stakeholders per company SOP requirements.
Complete the related payment procedure in systems on time, place order for FOC for the QC testing.
Assist QC testing and verification of in the national standard or panel verification or national /industrial standard.
Support the regulatory affair related work, including but not limited to payment, reagent order, achieving document management, warehouse management, etc.
As a member of RD, provide active and strong regulatory supports to internal dep. as needed.
Initiatively deal with daily works. Keep records. Have clear filing and maintain of all documents, update in RA related IT systems， share points, V drive on time.
Other projects or tasks assigned by line manager.
Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
Education& Qualifications
Bachelor degree or above, subject on medicine/bioengineering/clinical medicine/biochemistry or other related subjects.
Know medical device regulation.
Fluent English in listening, speaking, reading and writing.
Good skill on computer, MS-Office operation.
Experience
Love regulatory work, with related work experience in medical regulatory affairs preferred.
High enthusiasm and devotion, work hard and earnest
Willing to work under pressure, self-starting and self-inspiring
Be honest and open, excellent interpersonal communication skill, ability of social activity and collaboration
Innovating with good independent working ability
Energetic team spirit
A 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.