Mexico Regulatory Affairs Lead – COFEPRIS Expert

Amgen; Estado de México; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Amgen Mexico is seeking a Regulatory Affairs Manager to lead local regulatory strategies and lifecycle management for key therapies. You will coordinate submissions, label changes, and regulatory activities with COFEPRIS, ensuring timely approvals and compliance across product life cycles.

You will partner with Global and Regional Regulatory, Quality, Safety, Medical and Supply Chain teams to navigate Mexican regulations, assess risks, and drive successful launches while safeguarding patient

Formación

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or related field and 7 years in Regulatory Affairs.
• Proficiency in English, both spoken and written.
• 3+ years of experience managing regulatory submissions and lifecycle activities in Mexico.
• Strong knowledge of Mexican pharmaceutical legislation, COFEPRIS processes, and regulatory requirements for innovative products.

Responsabilidades

• Lead development and execution of local regulatory strategies for assigned products.
• Ensure timely submission, follow-up, and approval of new marketing authorizations and variations.
• Provide strategic local input to Global and Regional Regulatory teams to optimize development, registration, launch, and lifecycle-management plans.
• Assess regulatory risks, define mitigation strategies, and clearly communicate potential business, supply, and patient-access impacts.
• Ensure local labeling changes and artwork components are implemented in coordination with relevant functions.
• Support regulatory assessments related to product supply, manufacturing-site changes, and importation requirements.

Conocimientos

English proficiency

Regulatory affairs expertise

Educación

Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or related

Descripción del empleo

Amgen Mexico is seeking a Regulatory Affairs Manager to lead local regulatory strategies and lifecycle management for key therapies. You will coordinate submissions, label changes, and regulatory activities with COFEPRIS, ensuring timely approvals and compliance across product life cycles.

You will partner with Global and Regional Regulatory, Quality, Safety, Medical and Supply Chain teams to navigate Mexican regulations, assess risks, and drive successful launches while safeguarding patient