Career Category

Job Description

Senior Associate Regulatory Affairs

Full time job

Amgen Employee Contract for one year (possible to extend)

Reporting to Senior Manager Regulatory Affairs

Purpose of Job:

• Provision of local expertise, regulatory support for the development (clinical part), registration and lifecycle management of Amgen medicinal products authorized by the centralized procedure
• Responsibility for the allocated part of Amgen's drug portfolio
• Coordination and execution of regulatory submissions in accordance with corporate standards and local regulatory requirements
• Preparation, submission and electronic archiving of regulatory documentation per Amgen standards
• Cooperation with Quality department
• Operational support of Local Qualified Person
• Administrative support

Key activities:

• Ensure that applications are submitted on time and meet corporate and local legislative requirements
• Coordination and preparation of Czech source text (Product Information)
• Review of promotional and non-promotional materials
• Review and approval of marketed product artwork and for products in clinical trials
• Collaboration and communication with other members of regulatory team and other affiliate teams
• Cooperation and communication with regional/global regulatory teams

Qualifications and requirements:

• Master’s degree (scientific area) or Bachelor’s degree (scientific area) and 2 years of directly related experience

Knowledge & Skills

• Knowledge of Regulatory principles
• Working with policies, procedures and SOP’s
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
• General knowledge of Czech legislation and regulations relating to medicinal products
• Understanding of drug development
• Demonstrate ability to work in teams
• Ability to understand and communicate scientific/clinical information
• Excellent knowledge of English, native language Czech  
• Working on PC and related technical skills, very good knowledge of MS Office
• Precision, independent and responsible approach