Regulatory Affairs Specialist

hace 1 semana


Xico, México Amgen A tiempo completo

Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Amgen. As a key member of our regulatory team, you will be responsible for ensuring that our regulatory submissions are made on time and meet our corporate and local regulatory requirements.

Key Responsibilities

  • Develop and implement filing plans for regulatory submissions in Mexico.
  • Review and approve source text for country labeling and artwork.
  • Review and approve promotion and non-promotion materials.
  • Supervise changes in local trade associations, codes, and national legislation.
  • Assist in healthcare compliance activities.
  • Contribute to the affiliate/local office compliance framework.
  • Share relevant information with cross-functional teams.
  • Participate in local regulatory process improvements initiatives and training.
  • Lead external vendor/contractor relationships.
  • Collaborate with the Global Regulatory Team to support local planning and execution.
  • Exchange regulatory information and intelligence with other regulatory colleagues and cross-functional teams.

Requirements

  • Doctorate degree or equivalent experience in a related field.
  • Proficiency in English, both in oral and written communication.
  • Knowledge of Mexico legislation and regulations relating to medicinal products.
  • Regulatory principles and working knowledge of policies, procedures, and SOPs.
  • Teamwork and ability to communicate technical/scientific information.
  • Cultural awareness and sensitivity to achieve results across countries.

What We Offer

  • Full support and career-development resources to expand your skills and expertise.
  • A diverse and inclusive community of belonging.
  • Generous Total Rewards Plan, comprising health, finance, and wealth benefits.


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