Strategic CMC Regulatory Director

Clinical Dynamix, Inc.; San Diego (CA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Clinical Dynamix, Inc. is seeking a senior Regulatory CMC leader to drive regulatory strategy for commercial products and development projects.

This role oversees IND/CTA/MAA/NDA/BLA submissions, coordinating with cross-functional teams to ensure timely regulatory clearance and approvals. The ideal candidate has 12+ years in Regulatory Affairs with CMC focus, strong leadership, and proven experience negotiating marketing approvals in major markets.

Qualifications

• BS/BA degree with 12+ years in Regulatory Affairs focusing on CMC.
• Experience leading regulatory projects for small molecules, biologics, or gene therapies.
• Strong leadership and ability to negotiate marketing approvals.
• Extensive managerial experience.
• Knowledge of FDA and EMA drug regulations and guidance.

Responsabilités

• Lead regulatory CMC strategy for commercial/development projects and submissions (IND/CTA/MAA/NDA/BLA).
• Develop global CMC regulatory strategies to enable early approvals.
• Provide guidance to senior management and project teams on regulatory issues.
• Represent the company with regulatory agencies during development and registration.
• Manage preparation and review of regulatory submissions.

Connaissances

Leadership

Regulatory leadership

Cross-functional

Regulatory strategy

Communication

Formation

BS/BA degree

Master's degree

PhD

Description du poste

Clinical Dynamix, Inc. is seeking a senior Regulatory CMC leader to drive regulatory strategy for commercial products and development projects.

This role oversees IND/CTA/MAA/NDA/BLA submissions, coordinating with cross-functional teams to ensure timely regulatory clearance and approvals. The ideal candidate has 12+ years in Regulatory Affairs with CMC focus, strong leadership, and proven experience negotiating marketing approvals in major markets.