Monica Morales Bernal

Regulatory Affairs Specialist Latam Abbott @Abbott

Chicago, IL, US

As a Regulatory Affairs Specialist at Abbott, my responsibilities include:Label Development: Create and review labels for pharmaceutical products being launched or for which regulatory changes are requested in Latin American countries, ensuring compliance with local regulations and regional standards established by each Ministry of Health.Interaction with Affiliates: Work closely with affiliates in Latin America to ensure labels meet country-specific requirements.Coordination and collaboration with the Global Labeling Operations (GLO) team: to ensure label consistency and accuracy globally.Collaboration with Product Portfolio Managers (PPMs): Work with Product Portfolio Managers (PPMs) to align labeling strategies with product portfolio objectives.Interaction with Global Plants: Coordinate with various plants worldwide to request letters of support validating certain values ​of Abbott-manufactured formulas when required by local regulations.Use of Platforms: Utilize platforms such as Devex, Label Viewer, and M Files for label development and management. These responsibilities require meticulous attention to detail, effective communication skills, and a deep understanding of pharmaceutical regulations in Latin America.

Universidad de Guadalajara

Bachelor's degree, DDS (Doctor of Dental Surgery)

Tecnológico de Monterrey

Diploma of Education, Coaching, Leadership, Sales, in Management Skills.

Tecnológico de Monterrey

Diploma of Education, Management Skills Development.