Director Médico de Asuntos Regulatorios

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

About the Role

Our client, a globally respected pharmaceutical company committed to enhancing patient lives through groundbreaking medical advancements, is seeking an accomplished and strategic Director Médico de Asuntos Regulatorios to lead their regulatory affairs division in Ciudad Juárez, Chihuahua . This senior leadership role is paramount in ensuring that all pharmaceutical products meet stringent national and international regulatory standards for approval and marketing. You will be responsible for developing and executing comprehensive regulatory strategies, managing submissions, and fostering strong relationships with health authorities. This is an exceptional opportunity to shape regulatory policy and contribute significantly to the company's success and patient access to vital medications from their strategic base in Ciudad Juárez .

Key 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 (e.g., 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 working relationships.


• Provide expert regulatory guidance and strategic input to cross-functional teams, including R&D, clinical, marketing, and manufacturing.


• Monitor and assess the impact of evolving regulatory landscapes on the company's portfolio.


• Manage regulatory risk and develop mitigation strategies.


• Approve regulatory labeling and promotional materials.


• Contribute to the company's strategic planning and business development initiatives from a regulatory perspective.

Requirements

• Medical Doctor (MD) or Ph.D. in a relevant life science discipline.


• Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs, with significant experience in a leadership role.


• Demonstrated success in obtaining product approvals in key international markets.


• Deep understanding of global regulatory requirements, including GMP, GCP, and GLP.


• Proven experience in 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.

Benefits

Our client offers a highly competitive executive compensation package, including a substantial base salary, significant bonus potential, comprehensive executive health benefits, life insurance, a generous retirement plan, relocation assistance, and ample opportunities for professional development and global career progression. We provide a dynamic and intellectually stimulating work environment in Ciudad Juárez, Chihuahua , where your contributions directly impact global health. Join a leading pharmaceutical innovator.