Senior Regulatory Affairs Manager - Hybrid (Oncology)

MSD LATAM; México; Hybrid; MXN 900,000 - 1,500,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MSD LATAM in Mexico City is seeking a Regulatory Affairs Manager (Senior Specialist) to lead regulatory submissions, lifecycle management, and compliance for our pharmaceutical products.

The role requires strong expertise in COFEPRIS processes, cross-functional collaboration, and a proactive regulatory strategy to support timely approvals and product launches. You will coordinate with local teams, maintain regulatory files, and drive continuous improvement across the regulatory lifecycle.

Qualifications

• Degree in Pharmacy, Life Sciences, or related field.
• Minimum of 8 years in a Registration Department or equivalent with COFEPRIS experience.
• Strong knowledge of local legislation and guidelines for pharma products.
• Excellent verbal and written communication skills.

Responsibilities

• Lead timely submission of new Marketing Authorization applications and manage regulatory queries.
• Develop and execute local action plans to support authorization, launch, and lifecycle management.
• Ensure approvals are compliant; manage variations, renewals, and post-approval changes.
• Collaborate with cross-functional teams on regulatory activities including QNs, GMP inspections, and annual product reviews.

Skills

Regulatory affairs management

Regulatory submissions

Project management

Pharma regulatory affairs

English proficiency

GMP inspections

Quality notifications

COFEPRIS

Regulatory strategy development

Stakeholder management

Education

Bachelor's degree in Pharmacy / Life Sciences

Tools

Regulatory databases

Artwork Management System

Job description

MSD LATAM in Mexico City is seeking a Regulatory Affairs Manager (Senior Specialist) to lead regulatory submissions, lifecycle management, and compliance for our pharmaceutical products.

The role requires strong expertise in COFEPRIS processes, cross-functional collaboration, and a proactive regulatory strategy to support timely approvals and product launches. You will coordinate with local teams, maintain regulatory files, and drive continuous improvement across the regulatory lifecycle.