Regulatory Affairs Specialist for Brazilian Markets

1 dia atrás


São Paulo, São Paulo, Brasil Sully's Steamers Johnson City Tempo inteiro
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sully's Steamers Johnson City. This role will be responsible for coordinating, compiling, and submitting new drug/medical devices applications to regulatory agencies in Brazil.

Main Responsibilities:
  • Coordinate Regulatory Activities: Plan, conduct, and coordinate JJV regulatory activities for Brazil, ensuring timely and accurate submissions to regulatory agencies.
  • Develop Regulatory Strategies: In partnership with RA management, establish and execute Brazil regulatory strategies for new and existing products, aligning with JJV business priorities and global regulatory strategies.
  • Ensure Compliance: Work with RA management to ensure rapid and timely approval of new products and continued regulatory support of products marketed in Brazil, adhering to current and appropriate local regulatory expectations.
  • Support Regulatory Framework: Implement and maintain the appropriate regulatory framework (processes, procedures, standards, etc.) to facilitate efficiency and compliance, supporting the preparation of Brazil RA budget.
  • Provide Regulatory Advice: Offer regulatory advice to project teams, requesting and monitoring technical and legal documentation from companies worldwide to prepare regulatory submissions and files.
Required Skills and Qualifications:
  • Bachelor's degree with a minimum of 4 years of Regulatory experience in a regulated industry.
  • Fluent in English and Portuguese (both written and verbal), Spanish is a plus.
  • Result-oriented, initiative, proactive, team player with good communication skills (collaborative approach), open-minded, demonstrated ability to handle multiple projects.
  • Regulatory knowledge of Brazilian regulations in Medication or Medical Devices.
Additional Information:

This position is based at Sully's Steamers Johnson City, Brazil site, and may require up to 5–10% travel.

About the Salary:

The estimated salary for this role is around $80,000 - $120,000 per year, depending on experience and qualifications.



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