Regulatory Strategy Lead - Mexico City Team

Pfizer; Ciudad de México; Hybride; MXN 1 800 000 - 2 500 000; Plein temps

Résumé du poste

Pfizer in Mexico City is seeking a Senior Regulatory leader to direct regulatory teams, shape strategies for national and regional products, and partner with above-country hubs to ensure timely licensing and lifecycle management. You will drive cross-functional regulatory input, oversee MA submissions, and manage external relationships with authorities.

The role involves leading projects, building regulatory capability, and ensuring compliance with local and international regulations to support

Qualifications

• Life sciences or chemistry graduate to honours level or equivalent.
• Masters degree, Postgraduate Diploma or PhD preferred.
• Relevant Professional Qualifications desirable (e.g. MSc in Regulatory).
• Previous experience and proven track record in Regulatory (Human Medicinal Products).
• Previous experience and demonstrated line management capability and/or experience of coaching and mentoring.
• Computer literacy.
• Excellent written and verbal communication skills; Fluency in English/Spanish required.
• Proven strength in analytical thinking; Leadership capability.

Responsabilités

• Cluster & Project Management: identify, implement and manage key regulatory cluster/country projects; meet cluster regulatory objectives and priorities.
• People and Resource Management: manage performance of direct reports and workload; provide coaching and development.
• Deliver Regulatory Strategy and Advise Cross-Functional Teams: develop and deliver regulatory strategies to support country goals; represent Regulatory on cross-functional teams.
• Manage New Registration/Marketing Authorization Applications: coordinate pre-submission meetings and NRA engagements; develop submission strategy.
• Manage MA Variations and Renewals: coordinate local filing requirements and communication with NRAs.
• External Relationships: build and maintain relationships with regulatory authorities and trade associations; influence outcomes.
• Populate and Maintain Regulatory Databases: ensure accurate regulatory transactions; manage NRA approvals for supply of unlicensed medicines.

Connaissances

Leadership

Analytical thinking

Fluency in English/Spanish

Communication

Computer literacy

Formation

Masters degree or PhD preferred

Regulatory/Life sciences background

Postgraduate qualification desirable

Description du poste

Pfizer in Mexico City is seeking a Senior Regulatory leader to direct regulatory teams, shape strategies for national and regional products, and partner with above-country hubs to ensure timely licensing and lifecycle management. You will drive cross-functional regulatory input, oversee MA submissions, and manage external relationships with authorities.

The role involves leading projects, building regulatory capability, and ensuring compliance with local and international regulations to support