Develop and execute regulatory strategies ensuring compliance with applicable guidelines and directives
Take ownership of assigned regulatory projects, acting as the main point of contact
Manage preparations and follow up for new marketing authorizations and lifecycle maintenance
Prepare and manage local labelling documents in line with Company Core Data Sheet
Collaborate with internal stakeholders to ensure compliance and alignment across projects
Represent Regulatory Affairs in cross-functional teams and relevant meetings
Maintain accuracy and completeness of entries in the Regulatory Information Management System
Support business performance improvements by optimizing time-to-market

University degree in Life Sciences or a related field; advanced degree in Pharmaceutical Science an asset
At least 3 years of experience in Regulatory Affairs in the LATAM Region
Proven track record of collaborating with external partners within the pharmaceutical industry
Ability to analyze the regulatory requirements and perform comprehensive gap assessments
Fluent in English and Spanish, both written and spoken
Proficiency in MS Office; familiarity with Veeva Vault desirable

Regulatory Affairs Specialist – LATAM

Key skills