# HGRAC Specialist at Roche

Roche is hiring a HGRAC Specialist in Shanghai, China. Level rates it Little AI ●○○○; you can [apply on Roche](https://jobsbylevel.com/go/1db3c512-c75b-42fb-9728-2c170ff125b5?utm_medium=ai-agent).

AI Level 1, AI centrality 0 out of 100. Shanghai.

## Details

- Company: [Roche](https://jobsbylevel.com/companies/roche)
- AI level: AI Level 1 (score 0 out of 100)
- Location: Shanghai
- Posted: October 21, 2026
- Apply: https://jobsbylevel.com/go/1db3c512-c75b-42fb-9728-2c170ff125b5?utm_medium=ai-agent

## Prepare for this job

The job page lists 4 likely interview questions for this offer, with a CV checklist: https://jobsbylevel.com/jobs/hgrac-specialist-at-roche-c74a0c

## 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 Position Position Purpose: The HGRAC Specialist is r esponsible for all HGRAC applications for insourced and outsourced studies in China. Main responsibilities and accountabilities: Be responsible for HGRAC submission and review, including but not limited to the fulfillment of online application form, paper documents collection and paper dossier submission etc according to HGRAC regulation. Be responsible for the tracking of online application results. Regular update HGRAC officer for the reason of rejection and work together with CREL/SSUL for the application strategy and potential solution. Be familiar with the most updated HGRAC related regulation and act as subject matter expert to provide input for continuous improvement of Roche HGRAC application process set up, relevant management process and functional initiatives. Provide updated HGRAC information to global and local internal stakeholders and support management on strategic decision-making. Setup and maintain database to capture updated HGRAC regulations, lessons leant and FAQ. Participate in appropriate professional meetings, symposia, and continuing education programs to maintain knowledge and expertise across the industry. Perform other tasks, as assigned or requested by line manager. Qualifications: University Degree or equivalent, preferably in medical / science-related field. Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices(ICH-GCP), as well as understanding of the regulatory requirements for starting clinical trials in the relevant country. Competencies: Planning and Organizing – establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources. Communication – conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others. Building Partnerships – develops and leverages relationships within and across work groups to achieve results. Initiating Action - takes prompt action to accomplish work goals; takes actions to achieve results beyond what is required; is proactive. Work Standards – sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self – imposes standards of excellence rather than having standards imposed. Decision making – identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences. Adaptability – maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful. Influencing – uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes. Innovation – creates novel solutions

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/hgrac-specialist-at-roche-c74a0c

Source: https://jobsbylevel.com/jobs/hgrac-specialist-at-roche-c74a0c

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