• Participate in regulatory affairs activities, including preparation, submission, and maintenance of dossiers for pharmaceutical products, with emphasis on biological products.

• Ensure compliance with national and international pharmaceutical regulations, including ANVISA requirements and global guidelines.

• Act as the primary contact for regulatory authorities and certification bodies.

• Oversee quality assurance processes, including audits, inspections, and corrective/preventive actions.

• Develop, implement, and monitor Standard Operating Procedures (SOPs).

• Collaborate with cross-functional teams to ensure product quality and regulatory compliance.

• Support continuous improvement initiatives in quality systems.

• Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requireme...