Assoc. Spclst., Regulatory Affairs

29

Hybrid
Regulatory dossier preparation
Brazilian health legislation monitoring
Labeling and packaging text updates
This job posting seeks an Associate Specialist in Regulatory Affairs to support compliance with regulatory standards in a dynamic and collaborative environment. The role involves preparing regulatory submissions, analyzing technical documents, and maintaining regulatory records

Job Summary

  • The role involves supporting the evaluation and preparation of dossiers for new drug registrations and renewals in Brazil.
  • Candidates will monitor Brazilian sanitary legislation and assess the impact of new regulations on active ingredients and labeling.
  • The position requires organizing physical and electronic files, preparing standard operating procedures, and assisting with export certifications.

Matching Summary

Match Score: 85

This job posting seeks an Associate Specialist in Regulatory Affairs to support compliance with regulatory standards in a dynamic and collaborative environment. The role involves preparing regulatory submissions, analyzing technical documents, and maintaining regulatory records.

Skills & Requirements

Must-have

  • Regulatory dossier preparation
  • Brazilian health legislation monitoring
  • Labeling and packaging text updates
  • GMP certificate acquisition
  • Technical requirement responses

Nice-to-have

  • Analytical and organized mindset
  • Collaborative team environment
  • Strategic regulatory contribution
  • Internship supervision experience

Key Requirements

  • Experience with eCTD systems
  • Knowledge of ANVISA regulations
  • Document control system proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter