Regulatory Affairs Manager - Prague, Česká republika - Amgen

Popis

The Regulatory Affairs Manager at Amgen ensures the company's compliance with all regulations and laws pertaining to the company's business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company's products and services.

full time job / Level 5 / Temporary contract for 1 year

Purpose of Job:

• The Local Regulatory Representative (Manager) is assigned to all Amgen products.
• Assist in aligning local regulatory requirements with Amgen's corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Act as the point of contact with regulatory agencies.

Qualifications and requirements:

• Doctorate or Master's degree (scientific area) and 3 years of directly related experience OR Bachelor's degree (scientific area) and 5 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 national legislation and regulations relating to medicinal products.
• General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
• Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
• Understanding of drug development.
• Demonstrate strong team work ability.
• Good communication skills - both oral and written.
• Good negotiation and Influencing skills.
• Ability to understand and communicate scientific/clinical information.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.