R&D - Regulatory Affairs Supervisor - BJ
Beijing, China Fixed Term Posted on Apr. 09, 2025 Closing on Jun. 01, 2025JOB PURPOSE:
·Support Line manager/Submission team leader for implementing regulatory strategy to obtain the regulatory approval
·Responsible for part of the regulatory submission of new product Responsible for regulatory submission for group marketed products
ORGANIZATIONAL CONTEXT:
(See Organizational chart attached)
SUPERVISED RESOURCES:
(Sales, budget, headcount ... )
KEY ACCOUNTABILITIES:
·Support Line manager for implementing regulatory strategy to obtain the regulatory approval
·Support line Manager for the HA interaction for the strategy discussion and be accountable for the HAinteraction to facilitate the implementation process
·Support line manager for regulatory intelligence collection and analysis
·Prepare for the registration submission and approval timeline
·Follow up QC testing timely and troubleshooting together with Global technical support Prepare registration dossier and assure timely and high-quality submission
·Follow up closely with registration procedure and assure proactive interaction with HA and give timely feedback once there is a query
·Ensure all dossier and information kept on file based on company's requirements Maintain good relationship with officials and experts, both internal and external
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
·Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)
Experience & knowledge:
·2 years above in RA filed with recorded performance
Core competencies:
·Good computer skill in EXCEL, POWERPOINT and WORD;
·Good interpersonal communication skill;
·English skill both in spoken and written
nullPursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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Sanofi careers in China
From research and engineering to sales, we're all working toward the same ambitious goal – halving the time from discovery to therapy. Our people develop incredible careers, alongside 40 new innovative drugs and vaccines for China. We also support the national health department in preparing for China 2030. It's how we've become a China Top Employer and have continued to grow since opening our first China site in 1982.
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