At Gilead, we’re creating a healthier world for all people by developing therapies that help improve lives and ensuring access globally
Job Summary
At Gilead, we’re creating a healthier world for all people by developing therapies that help improve lives and ensuring access globally.
The role involves coordinating regulatory submissions for distributor countries and preparing submissions under Mexican requirements including CMC variations and labeling updates.
People leaders at Gilead are key drivers in evolving culture and creating an environment where employees feel included, developed, and empowered.
Matching Summary
At Gilead, we’re creating a healthier world for all people by developing therapies that help improve lives and ensuring access globally.
Skills & Requirements
Must-have
Regulatory submissions coordination
Knowledge of Mexican regulatory requirements
Labeling updates and renewals
Project status updates and strategy presentations
Excellent organizational skills
Verbal and written communication skills
Nice-to-have
Collaboration and team participation
Process improvement initiatives
Interpersonal skills
Knowledge of regulatory requirements in Colombia, Argentina, Chile, Uruguay
Key Requirements
10+ years experience in Regulatory Affairs
Degree in a scientific field preferred
In-depth knowledge of Mexican regulatory requirements
Experience with CMC variations and labeling
Ability to work under minimal direction
Experience with regulatory submissions in Latin America