Cellera Farma

Compliance

• Responsible for preparing regulatory dossiers to obtain approvals for new products and to maintain portfolio products
• Preparation of product registration and post-registration dossiers for submission to ANVISA
• Experience with CTD-format dossiers
• Review and approval of marketing/promotional materials
• Review and approval of package inserts and labeling
• Provide support to internal departments (marketing, manufacturing, R&D, etc.)
• Monitor and interpret regulatory changes to anticipate impacts on the company’s business
• Strategic market perspective with a focus on Regulatory Intelligence

Regulatory Affairs Analyst – Sr