Director Médico de Asuntos Regulatorios – Liderazgo Global

Placements24; Chihuahua; Hybrid; MXN 2,000,000 - 3,600,000; Full time

Job summary

Placements24 is seeking a Director Médico de Asuntos Regulatorios to lead its regulatory affairs division in Ciudad Juárez, Chihuahua. You will develop global regulatory strategies, manage submissions to COFEPRIS, FDA, and EMA, and mentor a high-performance team in a dynamic, international pharmaceutical setting.

The role requires 10+ years in regulatory affairs, strong leadership, and fluency in Spanish and English to navigate global compliance and drive product approvals across markets.

Qualifications

• Medical Doctor (MD) or Ph.D. in a life science discipline.
• Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs, with leadership experience.
• Proven success in obtaining product approvals in key international markets.
• Deep understanding of global regulatory requirements, including GMP, GCP, and GLP.
• Experience managing regulatory submissions (e.g., NDAs, MAAs, supplements).
• Exceptional strategic thinking, problem-solving, and decision-making skills.
• Strong leadership, team management, and interpersonal abilities.
• Excellent written and verbal communication skills in Spanish and English.
• Ability to navigate complex regulatory environments and influence stakeholders.
• Experience working in a Hybrid model and readiness to operate from Ciudad Juárez, Chihuahua.

Responsibilities

• Develop and implement global and regional regulatory strategies for product development, registration, and lifecycle management.
• Oversee the preparation, submission, and maintenance of regulatory dossiers to health authorities (COFEPRIS, FDA, EMA).
• Ensure compliance with all applicable pharmaceutical laws, regulations, and guidelines.
• Lead and mentor a team of regulatory affairs professionals, fostering a high-performance culture.
• Serve as the primary liaison with regulatory agencies, building and maintaining positive relationships.
• Provide expert regulatory guidance to cross-functional teams (R&D, clinical, marketing, manufacturing).
• Monitor and assess the impact of evolving regulatory landscapes on the portfolio.
• Manage regulatory risk and develop mitigation strategies.
• Approve regulatory labeling and promotional materials.
• Contribute to strategic planning and business development initiatives from a regulatory perspective.

Education

MD or PhD in life sciences

Job description

Placements24 is seeking a Director Médico de Asuntos Regulatorios to lead its regulatory affairs division in Ciudad Juárez, Chihuahua. You will develop global regulatory strategies, manage submissions to COFEPRIS, FDA, and EMA, and mentor a high-performance team in a dynamic, international pharmaceutical setting.

The role requires 10+ years in regulatory affairs, strong leadership, and fluency in Spanish and English to navigate global compliance and drive product approvals across markets.