Regulatory Affairs Jobs

Senior Manager Regulatory Affairs CZ&SK

**Contract type: Amgen staff, indefinite period, fulltime** CZ&SK Affiliate Regulatory Head, Sr Manager provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. **Job Summary:** The Cluster Regulatory Head (Sr. Manager) oversees the affiliate and manages a regulatory team to ensure delivery of assigned local and ELMAC Regulatory […]

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 […]

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