Mariana Cerna

Four-month internship program within the Regulatory Affairs department, supporting documentation management and regulatory activities for the pharmaceutical portfolio across Central America and the Caribbean.

• Key Responsibilities:
• Support post-registration changes, including the preparation of renewal and variation dossiers, and coordinate documentation required for health authority submissions.
• Coordinated cross-functional communication to streamline project timelines and enhance collaboration among regulatory teams.
• Conducted thorough reviews of documentation and labeling to verify accuracy and adherence to regulatory requirements.
• Maintained comprehensive records of regulatory activities, facilitating easy access to key information for team members and stakeholders.

Supported the Regulatory Affairs team in managing oncology and antiretroviral portfolios, ensuring alignment with local and global health authority requirements across Central America and the Caribbean.

• Monitored changes in regulations and guidelines, providing timely updates to relevant stakeholders to maintain compliance.
• Key Responsibilities:
• Prepared and tracked regulatory dossiers for marketing authorizations, renewals, and post-approval variations, ensuring compliance with internal procedures and regional regulations.
• Assisted in safety updates and post-marketing submissions to maintain product lifecycle compliance.
• Collaborated with Quality Assurance, Medical Affairs, and Pharmacovigilance on documentation control and inspection readiness.
• Ensured data integrity and inspection readiness through Veeva Vault RIM documentation management.