Assoc. Spclst., Regulatory Affairs

Merck & Co., Inc.

Hybrid
Regulatory dossier preparation
Brazilian health legislation analysis
Labeling and packaging text updates
Merck & Co., Inc. is seeking an Associate Specialist in Regulatory Affairs who is organized, analytical, and passionate about regulatory matters. The position involves supporting the evaluation and preparation of regulatory submissions, maintaining documentation, and ensuring compliance with health regulations in a collaborative and dynamic environment

Job Summary

  • The role involves supporting the evaluation and preparation of dossiers for new drug registrations and renewals.
  • Candidates will monitor Brazilian sanitary legislation and assess the impact of new regulations on active ingredients.
  • The position requires organizing regulatory files, updating labeling texts, and assisting with GMP certification requests.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Specialist in Regulatory Affairs who is organized, analytical, and passionate about regulatory matters. The position involves supporting the evaluation and preparation of regulatory submissions, maintaining documentation, and ensuring compliance with health regulations in a collaborative and dynamic environment.

Skills & Requirements

Must-have

  • Regulatory dossier preparation
  • Brazilian health legislation analysis
  • Labeling and packaging text updates
  • GMP certificate acquisition
  • Electronic document management

Nice-to-have

  • Analytical mindset
  • Collaborative team player
  • Strategic thinking
  • Adaptability in dynamic environment

Key Requirements

  • Experience with ANVISA regulations
  • Knowledge of eCTD standards
  • Ability to draft technical responses

Work Rights

Not specified

Tailored Resume

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