Senior Director, Regulatory Strategy – Oncology

BioSpace; Brisbane (CA); On-site; USD 232,000 - 331,000; Full time

Job summary

Nurix Therapeutics, Inc. is seeking a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team.

The successful candidate will develop and execute the global regulatory strategy in collaboration with internal stakeholders, and lead high-quality nonclinical and clinical submissions in support of registration and lifecycle management. The role interacts with global Health Authorities (FDA, EMA) and cross-functional teams to support regulatory filings

Qualifications

• Minimum 12 years in regulatory affairs strategy.
• Experience with oncology (solid tumors) programs.
• Strong knowledge of FDA/EMA/ICH guidelines and regulations.

Responsibilities

• Develop a comprehensive regulatory strategy that covers global requirements for product development and regulatory submissions.
• Identify risks and mitigation strategies for proposed strategies.
• Represent Regulatory Affairs on cross-functional development teams.
• Lead and manage high-quality global submissions (INDs, CTAs, NDAs, MAAs) for early and late-stage programs.

Skills

Regulatory strategy

Cross-functional collaboration

Project management

Regulatory submissions planning

Education

Bachelor's degree in life-sciences or related field

Job description

Nurix Therapeutics, Inc. is seeking a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team.

The successful candidate will develop and execute the global regulatory strategy in collaboration with internal stakeholders, and lead high-quality nonclinical and clinical submissions in support of registration and lifecycle management. The role interacts with global Health Authorities (FDA, EMA) and cross-functional teams to support regulatory filings