Regulatory Affairs Specialist

1 semana atrás


Rio de Janeiro, Rio de Janeiro, Brasil Octapharma Tempo inteiro

**About the Role**:

Octapharma is seeking a highly skilled Regulatory Affairs and Quality Analyst to join our team in Brazil. As a key member of our Regulatory Affairs Department, you will play a crucial role in ensuring compliance with Brazilian and global regulatory requirements for the development, manufacturing, and distribution of human protein products.

**Key Responsibilities**:

  • Support the preparation of regulatory dossiers for product registration, post-registration, and renewals at Anvisa.
  • Maintain the validity of GMP granted by Anvisa for all Octapharma and supplier sites.
  • Review packaging materials according to local legislation and Octapharma guidelines.
  • Support pharmacovigilance activities in Brazil, including adverse event receipt, communication, and treatment.
  • Handle quality and service deviations, complaints, and recalls according to Brazilian legislation and Octapharma procedures.
  • Develop and update SOPs, and train the team as needed.

**Requirements**:

  • Bachelor's degree in Pharmacy.
  • Advanced English skills.
  • Knowledge of Anvisa's regulations for biologic products.
  • Excellent written and verbal communication skills, and interpersonal skills.
  • Analytical profile focused on results and deadlines.

**About Octapharma**:

Octapharma is a leading global company in the development and production of human proteins. We have a strong commitment to patient care and strive to improve lives through our therapies.



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