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157

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北京市, C22
group leader in 北京市, C22

R&D - GRA - Regulatory Affair Supervisor - BJ

Sanofi -
北京市

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职位详情

合同工

完整职位描述

JOB 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 HA interaction 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

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