Regulatory Expert Sr. Specialist

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 Position

Job Summary:

the registration dossiers and get the approval according to the registration plan with compliance the regulations and SOP manner.

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

company requirements cross check for the registration dossier to make sure the accuracy and truthfulness of the registration dossiers.

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

working together with COand CCOEteamsto provide the regulatory supports on time.

the cross cooperation with other department.

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

Main Tasks& Responsibilities:

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 driveand notify all the stakeholders per company SOP requirements.

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 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 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 managers 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&D 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

Who we are

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.