Career Category

Job Description

Job Summary:

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support an LRR or lead a program under the supervision of an experienced Local Regulatory Lead.

• 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.

Education & Experience (Basic)

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

Knowledge and Skills

• In-depth regulatory experience and/or related to the country(ies).
• Depth knowledge of country(ies) legislation and regulations relating to medicinal products.
• 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.
• Understanding of drug development.
• Demonstrate ability to work in teams.
• Ability to understand and communicate scientific/clinical information.

This is a 12 month contract. Candidate must meet labor law eligibility to work in Malaysia.