Strategic Regulatory Affairs Lead, Mexico

Amgen SA; Ciudad de México; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Amgen in Mexico City is seeking a Regulatory Affairs Manager to lead local regulatory strategies, submissions and lifecycle management for assigned products. You will coordinate with COFEPRIS and cross-functional teams to ensure timely approvals and compliant labeling changes.

The role requires a solid regulatory background, 7+ years in Regulatory Affairs, and strong English communication. This position emphasizes cross-functional leadership and strategic risk management within a dynamic

Formación

• Bachelor’s degree in pharmacy, chemistry, biology, biotechnology or related field with 7+ years in Regulatory Affairs.
• Proficiency in English, both in oral and written communication.
• Minimum 3 years of experience managing regulatory submissions and product lifecycle activities in Mexico.
• Strong knowledge of COFEPRIS processes and regulatory requirements.

Responsabilidades

• Lead local regulatory strategies and filing plans for assigned products.
• Ensure timely submission, follow-up, and approval of new marketing authorizations, variations, renewals, extensions, and labeling updates.
• Provide strategic input to Global/Regional teams to optimize development and lifecycle plans.
• Identify regulatory risks and define mitigation strategies.
• Coordinate labeling changes with cross-functional teams.
• Support regulatory assessments related to supply and manufacturing changes.

Conocimientos

Regulatory affairs

English proficiency

Educación

Bachelor's degree in Pharmacy, Chemistry, Biology, Biotechnology, or related field

Descripción del empleo

Amgen in Mexico City is seeking a Regulatory Affairs Manager to lead local regulatory strategies, submissions and lifecycle management for assigned products. You will coordinate with COFEPRIS and cross-functional teams to ensure timely approvals and compliant labeling changes.

The role requires a solid regulatory background, 7+ years in Regulatory Affairs, and strong English communication. This position emphasizes cross-functional leadership and strategic risk management within a dynamic