Regulatory Affairs Specialist

• Filling 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.
• Per company requirements, cross check for the registration dossier to make sure the accuracy and truthfulness of the registration dossiers.
• Establish and maintain the good and closed relationship with NMPA testing centers. And successfully gains product QC testing reports per registration forecast plan.
• Close working together with CO and CCOE team to provide the regulatory supports on time.
• Provide the cross cooperation with other departments.
• Establish and maintain the good relationship with key contacts. Recommend valuable suggestion to company.

• With strong ownership, execute and complete multiple projects on time according to the registration plan, and proactively track and ensure the implementation of the plan. The awareness to influence the reviewers throughout the whole registration process.
• Make sure the accuracy and truthfulness of the registration dossiers and maintain all the submission and approved dossiers in related IT systems, 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.
• Working together with RAM, active join the discussion and verification of in the national standard or panel verification or national /industrial standard discussion and verification.
• Working together with global team, to draft the PTR and complete the type testing on time if needed.
• 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 information on time based on relevant requirements.
• The awareness for risk assessment; Capability to identify potential risks from various sources and propose mitigation plan.
• Understanding registration strategy and expectations for deliverables; the awareness to try innovation registration strategy. Escalate potential risks, issues and difficulties to LM to actively seek for solutions. Build good collaborative relationships
• 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.

• Bachelor degree or above, relevant subject on medicine/bioengineering/clinical medicine/ biochemistry or pharmacy.
• Medicine/bioengineering/clinical medicine/ biochemistry or pharmacy relevant background.
• Familiar with relevant NMPA registration regulation and policies.
• Familiar with English communication at the workplace
• Good skill on computer, MS-Office operation.

• 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.
• 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. Handle routine/complex registration cases independently.
• Energetic team spirit
• Capability to challenge and ask questions with negotiation awareness and skills.

• Demonstrate Roche values of Integrity, Courage, Passion
• The Core Competencies is identified as being most crucial for success in this role please refer to “Roche China University Website - Career Development - Platform”

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