Cw-regulatory Affairs Associate/senior Associate

Amgen

Bachelor's degree in scientific area
Knowledge of regulatory principles
Understanding of drug development
The role involves local coordination and execution of regulatory submissions in compliance with corporate standards

Job Summary

  • The role involves local coordination and execution of regulatory submissions in compliance with corporate standards.
  • Responsibilities include creating and reviewing source text for country labeling and coordinating translation for local submissions.
  • The position requires partnering with Regional Regulatory Leads to support the lifecycle management of company molecules.

Matching Summary

The role involves local coordination and execution of regulatory submissions in compliance with corporate standards.

Skills & Requirements

Must-have

  • Bachelor's degree in scientific area
  • Knowledge of regulatory principles
  • Understanding of drug development

Nice-to-have

  • Ability to work in teams
  • Experience with external vendor relationships
  • Strong communication skills for scientific information

Key Requirements

  • Bachelor's degree in scientific area or related field
  • Working knowledge of policies, procedures, and SOPs
  • Comprehensive understanding of regulatory activities

Work Rights

Not specified

Tailored Resume

Cover Letter