Career Category

Job Description

Regulatory Affairs Manager

Type: Full time job

Line mgr: Senior Manager Regulatory Affairs

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.