Senior Regulatory Strategy Lead - Neuroscience Therapies

Azza HealthCare Agency; Deerfield (IL); Sur place; USD 150 000 - 230 000; Plein temps

Résumé du poste

Azza HealthCare Agency is seeking a Senior Manager of Regulatory Strategy to lead U.S. and global regulatory planning for innovative neuroscience therapies.

This role drives submissions (INDs/NDAs/sNDAs), ensures alignment with FDA/ICH requirements, and coordinates cross-functional teams to shape strategy from development through post-approval. Strong leadership and communication skills are essential for agency interactions and risk assessment.

Qualifications

• Experience in regulatory strategy within the pharmaceutical or biotech industry.
• Deep understanding of FDA/ICH regulations and submission processes.
• Strong leadership and cross-functional collaboration skills.
• Ability to interpret regulatory requirements and guide strategic planning.
• Excellent communication skills for agency interactions and team coordination.

Responsabilités

• Lead U.S. and global regulatory strategies for innovative neuroscience therapies.
• Drive regulatory planning from early development through post-approval phases.
• Ensure compliance with FDA/ICH requirements and align strategies with company objectives.
• Guide preparation and submission of regulatory documents such as INDs, NDAs, and sNDAs.
• Lead interactions with regulatory agencies and assess associated risks.
• Influence portfolio decisions through strategic regulatory insights.

Connaissances

Regulatory strategy experience

FDA/ICH regulations

Leadership

Cross-functional collaboration

Regulatory planning & interpretation

Description du poste

Azza HealthCare Agency is seeking a Senior Manager of Regulatory Strategy to lead U.S. and global regulatory planning for innovative neuroscience therapies.

This role drives submissions (INDs/NDAs/sNDAs), ensures alignment with FDA/ICH requirements, and coordinates cross-functional teams to shape strategy from development through post-approval. Strong leadership and communication skills are essential for agency interactions and risk assessment.