Director Global de Asuntos Regulatorios (Remoto)

Placements24; San Luis Potosí; Hybrid; MXN 3,358,000 - 4,850,000; Full time

Job summary

Placements24 seeks an experienced Director of Global Regulatory Affairs to lead international regulatory strategy and submissions, guiding the company through global approvals from a fully remote setting.

The role requires oversight of INDs, CTAs, NDAs, MAAs, and post-approval variations, and close collaboration with R&D, clinical operations, and manufacturing to ensure compliant, timely approvals worldwide.

Qualifications

• Advanced degree in life sciences or medical field plus extensive regulatory affairs experience.
• 12+ years in global regulatory affairs with at least 5 years in leadership.
• Proven track record in global regulatory strategy development and major market approvals.

Responsibilities

• Develop and execute global regulatory strategies across pipelines and marketed products.
• Oversee international regulatory submissions (INDs/CTAs/NDAs/MAAs) and post-approval variations.
• Engage with health authorities (FDA/EMA/PMDA/COFEPRIS) and manage a global regulatory affairs team.

Skills

Regulatory leadership

Regulatory strategy

International regulatory

Strategic communication

Education

Ph.D./M.D./Pharm.D. or equivalent

Job description

Placements24 seeks an experienced Director of Global Regulatory Affairs to lead international regulatory strategy and submissions, guiding the company through global approvals from a fully remote setting.

The role requires oversight of INDs, CTAs, NDAs, MAAs, and post-approval variations, and close collaboration with R&D, clinical operations, and manufacturing to ensure compliant, timely approvals worldwide.