Director de Asuntos Regulatorios Globales

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

About the Role

Our client, a dynamic and rapidly growing global biopharmaceutical company, is actively seeking an experienced and visionary Director de Asuntos Regulatorios Globales to lead their international regulatory strategy. This executive-level, fully remote position is critical for guiding the company through the complex landscape of global drug approvals and compliance. You will be responsible for shaping regulatory strategies across all major markets, ensuring timely submissions, and fostering key relationships with health authorities worldwide. This is a unique opportunity to play a pivotal role in bringing life-saving and life-changing therapies to patients globally from a remote work setting, driving the company's international expansion and success.

Key Responsibilities

• Develop and execute comprehensive global regulatory strategies for the company's pipeline and marketed products.
• Oversee all aspects of international regulatory submissions, including INDs, CTAs, NDAs, MAAs, and post-approval variations.
• Ensure adherence to global regulatory requirements, guidelines, and best practices (e.g., ICH, FDA, EMA, PMDA, COFEPRIS).
• Manage and mentor a high-performing global regulatory affairs team, fostering collaboration and professional development.
• Serve as the primary interface with international health authorities, building and maintaining strong, proactive relationships.
• Provide strategic regulatory input and guidance to R&D, clinical operations, manufacturing, and commercial teams.
• Conduct regulatory intelligence activities to stay ahead of evolving global regulatory trends and anticipate challenges.
• Develop and implement global regulatory policies and procedures.
• Manage regulatory aspects of due diligence for potential partnerships and acquisitions.
• Lead cross-functional teams to achieve global regulatory milestones and objectives.

Requirements

• Advanced scientific degree (Ph.D., M.D., Pharm.D.) or equivalent experience.
• Minimum of 12 years of progressive experience in global regulatory affairs within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership capacity.
• Proven track record of successful global regulatory strategy development and execution, including major market approvals.
• Extensive experience with diverse regulatory submission types and global health authority interactions.
• Deep understanding of drug development processes, clinical trials, and CMC requirements.
• Exceptional strategic thinking, negotiation, and communication skills.
• Demonstrated ability to lead and inspire geographically dispersed teams.
• Fluency in English; proficiency in other major languages is a plus.
• Experience with a variety of therapeutic areas is advantageous.
• Ability to thrive in a fast-paced, innovative, and fully remote environment.

Benefits

Our client offers a highly competitive executive compensation package, including a significant base salary, substantial equity options, performance bonuses, comprehensive global health benefits, life insurance, a generous retirement plan, flexible working hours, and unparalleled opportunities for career growth within a leading biopharmaceutical company. This fully remote position offers exceptional autonomy and the chance to make a global impact from anywhere.