Regulatory Affairs Senior Associate

hace 4 semanas


Xico, México Amgen Sa A tiempo completo

Job Summary

Amgen Sa is seeking a highly skilled Regulatory Affairs Senior Associate to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the timely and compliant submission of regulatory documents for our products in Mexico.

Key Responsibilities

  • Develop and execute the filing plan for Mexico, ensuring compliance with local and corporate regulatory requirements.
  • Prepare and review source text for Mexico country-specific labeling, ensuring accuracy and compliance.
  • Review and approve promotion and non-promotion materials, ensuring they meet regulatory requirements.
  • Communicate effectively with cross-functional teams to ensure timely and accurate exchange of regulatory information.
  • Collaborate with regulatory colleagues and cross-functional teams to improve local regulatory processes and procedures.
  • Update and maintain internal regulatory systems and tracking tools, ensuring compliance with internal policies and standard operating procedures.
  • Develop and execute the local strategy to obtain new Marketing Authorizations for assigned business units, ensuring compliance with local and current regulations and procedures.
  • Analyze technical, scientific, and legal information to prepare dossiers for innovative products, ensuring compliance with all applicable requirements and guidelines.

Requirements

  • Master's degree or equivalent in a relevant field, or Bachelor's degree with 2 years of experience in a similar role.
  • Proficiency in English, both in oral and written communication.

About Amgen Sa

Amgen Sa is a global biotechnology company dedicated to serving patients through the discovery, development, and delivery of innovative medicines. We are committed to making a meaningful difference in the lives of patients and to advancing the field of biotechnology.



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