Regulatory Affairs Manager

**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, regulatory policy and technical Regulatory guidance relating to Amgen pipeline.
+ Provide regulatory support for Therapeutic Areas/Scientific Affairs activities.
+ Where applicable, oversee external vend...

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