Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
Job Summary:
1.Filling the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner.
2.Make sure the accuracy and truthfulness of the registration dossiers. Maintain the registration and approved dossiers per company requirements.
3.Per company requirements, cross check for the registration dossier to make sure the accuracy and truthfulness of the registration dossiers.
4.Establish and maintain the good and closed relationship with NMPAtesting centers. And successfully gains product QC testing reports per registration forecast plan.
5.Close working together with COand CCOEteamsto provide the regulatory supports on time.
6.Provide the cross cooperation with other department.
7.Establish and maintain the good relationship with key contacts. Recommend valuable suggestion to company.
Main Tasks& Responsibilities:
1.Prepare the registration dossier to submit to NMPA and obtain the approval to meet the registration plan.
2. 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.
3.Complete the related payment procedure in systems on time, place order for FOC for the QC testing.
4. Active join the discussion and verification of in the national standard or panel verification or national/industrial standard discussion and verification.Guide and influence the formulation of Standards
5. Working together with global team, to draft the PTR and complete the type testing on time if needed.
6. Active involve the regulation, guidance discussion, provide the feedback to authority aligned with Roche Regulatory Strategy.Guide and influence the formulation of guidelines.
7. As a member of RD, provide active and strong regulatory supports to internal dep. as needed.
8. Initiatively deal with daily works. Keep records. Have clear filing and maintain of all documents, update information on time based on relevant requirements.
9. Productively work-share in multi-functional teams with different perspectives and approaches. Proactively resolve issues; Build effective networks and maintain efficient cross-functional collaboration.
10. Proactively identify and assess regulations and relative changes, and contribute constructive ideas on key project registration strategies.
11. Handle risk assessment, risk levels and risk analysis; Proactively anticipate regulatory risks throughout the product line lifecycle, and figure out the mitigation plan in advance.
12. Figure out registration strategies, and propose innovative registration strategies with appropriately regulation and resources, to accelerate the product launch.
13. Manage stakeholder expectations from BAs' perspective; proactively and strategically facilitate project completion for cross-functional teams while ensuring time limit, budgets and compliance.
14. Other projects or tasks assigned by line manager.
15. 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.
16. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).
Basic Requirements of the Job
Education& Qualifications:
1. Bachelor degree or above, relevant subject on medicine/bioengineering/clinical medicine/ biochemistry or pharmacy.
2. Medicine/bioengineering/clinical medicine/biochemistry or pharmacy relevant background.
3. Expertise in NMPA registration regulations/policies.
4. Fluent English in listening, speaking, reading and writing.
5. Good skill on computer, MS-Office operation.
Experience:
1. Have not less than 5 years about experience in medical regulatory affairs, have the experience in the R of IVD products or IVD regulatory will be better, and expertise in relevant Standards/guidelines for registration.
2. High enthusiasm and devotion, work hard and earnest.
3. Willing to work under pressure, self-starting and self-inspiring.
4. Be honest and open, excellent interpersonal communication skill, ability of social activity and collaboration.
5. Innovating with good independent working ability.
6. Energetic team spirit.
7. Optimizations by challenge and asking questions; Familiar with negotiation skill.
Values& Core Competencies:
1. Demonstrate Roche values of Integrity, Courage, Passion
2. Follow Roche Operating Principles
3. Equip with the core skillsets as required by this role
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
