Regulatory Affairs Specialist
Há 1 mês
**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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