Regional Regulatory Lead for QOL Initiatives

Katalyst CRO; Dallas (TX); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Katalyst CRO seeks a Senior Director of Regulatory Affairs to lead regional QOL regulatory strategies in the US and globally. The role partners with cross-functional teams to ensure alignment with FDA and ICH guidelines and to drive submissions and inspections readiness.

The candidate will guide regional strategies, manage regulatory risks, and provide strategic oversight to the regulatory team. Travel up to 10% domestically and internationally is required.

Formación

• Bachelor's degree in life sciences or related field required; advanced degree preferred.
• Minimum 5+ years in regulatory affairs within pharma/biotech with branded products experience.
• Strong knowledge of FDA regulations and ICH guidelines; global submission experience beneficial.

Responsabilidades

• Lead regional regulatory strategies for QOL initiatives; provide strategic oversight.
• Support submission planning and regulatory document preparation for QOL programs.
• Collaborate cross-functionally to integrate regulatory considerations into development and manufacturing.
• Engage with regional authorities to negotiate and communicate on QOL initiatives.
• Monitor regulatory developments and advise leadership on risks and opportunities.
• Support post-marketing activities including variations, renewals, and labeling updates.
• Ensure inspection readiness and prepare documentation for regulatory inspections.
• Coordinate with global counterparts to align regional submissions with global plans.

Conocimientos

Cross-functional leadership

Regulatory strategy development

FDA & ICH knowledge

Effective communication

Travel coordination

Educación

Bachelor's in life sciences

Advanced degree (MS/PhD)

Descripción del empleo

Katalyst CRO seeks a Senior Director of Regulatory Affairs to lead regional QOL regulatory strategies in the US and globally. The role partners with cross-functional teams to ensure alignment with FDA and ICH guidelines and to drive submissions and inspections readiness.

The candidate will guide regional strategies, manage regulatory risks, and provide strategic oversight to the regulatory team. Travel up to 10% domestically and internationally is required.