Regulatory Affairs Specialist

hace 4 semanas

Xico, México Amgen Sa A tiempo completo

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amgen Sa. 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 the filing plan for Mexico, ensuring compliance with local 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 regulatory compliance.
  • Communicate relevant information to team members in advance, ensuring seamless collaboration.
  • Participate in local regulatory process improvements initiatives, driving efficiency and effectiveness.
  • Collate, distribute, and exchange regulatory information with other regulatory colleagues and cross-functional teams, providing expert advice on local regulatory considerations.
  • 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, 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.
  • Knowledge and experience in Mexican regulation relating to medicinal products and diverse portfolio of small molecules, innovative biotechs, biosimilars, and orphan drugs.
  • Knowledge of drug development scientific/technical excellence.
  • Experience in regulatory processes with Cofepris for a portfolio of innovative products: New Marketing Authorizations, variations, and renewals.

What We Offer

  • Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential.
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
  • Generous Total Rewards Plan, comprising health, finance, and wealth, work-life balance, and career benefits.

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