Merck seeks a Senior Specialist in Regulatory Affairs for its oncology portfolio in Mexico City. The role focuses on preparing and submitting marketing authorization applications, maintaining regulatory compliance, and managing the product lifecycle with Mexico's health authority (Cofepris).
Responsibilities
Prepare, submit, and manage new marketing authorization applications with health authorities
Handle regulatory queries and negotiate approval outcomes for product registrations
Maintain assigned product authorizations through variations, renewals, and lifecycle management
Ensure compliance with local regulations and manage regulatory files and databases
Coordinate cross-functional activities including quality notifications, GMP inspections, and annual reviews
Requirements
Pharmacy, Life Sciences, or related degree
Minimum 8 years in registration or equivalent regulatory role
Proven experience with Cofepris and local Mexican pharmaceutical regulations
Oncology industry experience with biologics, biotechnology, or small molecules
Advanced written and verbal communication skills
Fluent English proficiency