About the Role
**Regulatory Affairs Manager- China**
Reporting to: Head of Regulatory Strategy, China RA
Based in: Beijing
**Job Description**
+ Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.
+ Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.
+ Developing (with manager’s guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
+ Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
+ Participate in the local implementation of key Regulatory projects.
+ Maintains an awareness of new and developing legislation, regu...
Reporting to: Head of Regulatory Strategy, China RA
Based in: Beijing
**Job Description**
+ Applying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.
+ Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.
+ Developing (with manager’s guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
+ Undertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.
+ Participate in the local implementation of key Regulatory projects.
+ Maintains an awareness of new and developing legislation, regu...
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