- Provide regulatory inputs in new project development strategy discussion;
- Lead or coordinate both local and global team on registration plan;
- To solve the regulatory issues via communication and negotiation with HAs if necessary; Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);
- Lead or chair the CPT meetings for responsible project and be accountable to provide regulatory support to other functional team; Contribute to optimize DRA internal operational procedures whenever is needed
- Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs/WIs during routine work;
- Monitor regulatory changes and report to department head timely; Support line manager to control project cost according to budget; Coach the junior levels ;
- Acting as deputy in the absence of the department head and lead team daily operation.
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Regulatory Affairs Manager - Beijing, 中国 - Novartis
描述
About the role:
In this role, you will be accountable for regulatory strategy development and the implementation of the registration strategy in China.
Key Responsibilities:
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