Senior Global Regulatory Scientist

This is a fully remote position, open to applicants in Mexico, +3 more countries.

📋 Description

• Offer advanced regulatory and scientific expertise to enhance global development strategies and submissions.

• Spearhead the creation of global regulatory strategies for clinical programs, including strategies for key health authority interactions and milestones.

• Draft and review intricate regulatory documents such as clinical trial applications, briefing books, and major submission components.

• Analyze evolving global regulations, guidelines, and precedents, providing teams with insights on their implications for program design and execution.

• Contribute strategic insights into clinical development plans, risk management strategies, and labeling considerations.

• Represent regulatory functions in sponsor and health authority meetings, ensuring clear and scientifically robust communication.

• Guide junior regulatory staff and aid in the development of internal best practices, templates, and knowledge-sharing initiatives.

⛳️ Requirements

• A Bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Extensive experience in regulatory affairs or regulatory science within pharmaceutical, biotech, or CRO settings.

• Strong understanding of global clinical development regulations (e.g., FDA, EMA, ICH) and regional requirements.

• Exceptional scientific, analytical, and critical-thinking abilities, with a talent for integrating complex data into regulatory positions.

• Excellent written and verbal communication skills, with a strong attention to detail.

• Demonstrated experience in interactions with health authorities and leading cross-functional regulatory projects.

• Openness to travel as necessary (approximately 10%).

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.