Director / Sr. Director, Regulatory Strategy – Oncology

BioSpace; Brisbane (CA); Presencial; USD 232.000 - 331.000; Jornada completa

Descripción de la vacante

Nurix Therapeutics, Inc. seeks a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to lead global regulatory strategy and oversee registrations and lifecycle management across programs.

This role partners with the SVP and cross-functional teams to ensure high-quality submissions and strategic global regulatory input. The position emphasizes IND/CTAs/NDAs/MAAs preparation, efficient agency interactions, and strict adherence to SOPs, with a focus on accelerating

Formación

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Minimum 12 years in regulatory affairs with oncology experience.
• Strong knowledge of FDA, EMA, ICH guidelines.
• Experience planning and supporting global regulatory filings for major programs.
• Excellent project management and communication skills.
• Ability to lead cross-functional teams and manage multiple projects.

Responsabilidades

• Develop and execute global regulatory strategy across programs.
• Lead preparation of high-quality submissions (IND/CTAs/NDAs/MAAs).
• Coordinate regulatory agency interactions and meetings.
• Collaborate with clinical development and regulatory teams.
• Mentor junior staff and manage timelines.

Conocimientos

Regulatory strategy

FDA knowledge

EMA knowledge

IND/CTAs/NDAs/MAAs

Cross-functional collaboration

Educación

Bachelor9s degree in life sciences

Herramientas

Veeva RIM

Smartsheet

Excel

Descripción del empleo

Nurix Therapeutics, Inc. seeks a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to lead global regulatory strategy and oversee registrations and lifecycle management across programs.

This role partners with the SVP and cross-functional teams to ensure high-quality submissions and strategic global regulatory input. The position emphasizes IND/CTAs/NDAs/MAAs preparation, efficient agency interactions, and strict adherence to SOPs, with a focus on accelerating