Chief Quality & Regulatory Officer

Nucleus RadioPharma, Inc.; United States; Presencial; USD 225.000 - 290.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Health insurance

Descripción de la vacante

Nucleus RadioPharma is seeking a Vice President of Quality & Regulatory Affairs to architect and scale a global QMS and regulatory framework in a high-growth CDMO. You will lead a strategic, hands-on team across Quality, Regulatory, and Training, ensuring regulatory readiness and patient safety.

Reporting to the CTOO and as a core member of the Operations Leadership Team, you will drive compliance across manufacturing and commercialization, building partnerships with regulators and clients while

Formación

• 15+ years in quality and regulatory affairs within biopharmaceutical or radiopharmaceutical industries.
• Leadership experience in startup or high-growth environments.
• Deep knowledge of global regulatory frameworks (FDA, EMA, Health Canada, PMDA, ICH).

Responsabilidades

• Develop and execute a global quality and regulatory strategy aligned with company goals.
• Build and scale a comprehensive QMS and regulatory framework supporting rapid growth.
• Oversee regulatory submissions (IND/CTA/NDA/MAA) and inspection readiness across sites.
• Lead cross‑functional teams and stakeholder engagement with regulators and clients.
• Foster a culture of accountability, continuous improvement, and patient safety.

Conocimientos

Quality leadership

Regulatory strategy

Cross-functional leadership

Risk management

Educación

Bachelor's degree in Life Sciences or Engineering

Master’s preferred

Herramientas

QMS platforms

Descripción del empleo

Nucleus RadioPharma is seeking a Vice President of Quality & Regulatory Affairs to architect and scale a global QMS and regulatory framework in a high-growth CDMO. You will lead a strategic, hands-on team across Quality, Regulatory, and Training, ensuring regulatory readiness and patient safety.

Reporting to the CTOO and as a core member of the Operations Leadership Team, you will drive compliance across manufacturing and commercialization, building partnerships with regulators and clients while