Senior Manager, Regulatory Strategy - Hematology/Oncology

BioSpace; Brisbane (CA); On-site; USD 188,000 - 231,000; Full time

Job summary

Nurix Therapeutics, a clinical-stage biopharmaceutical company, seeks a Regulatory leader to help build and execute global regulatory strategy for development and future marketing of products. You will work within the Regulatory team and interact with global authorities to ensure compliant submissions and lifecycle management.

The role requires 8+ years in Regulatory affairs strategy, deep knowledge of FDA/EMA/ICH guidelines, and strong cross-functional collaboration.

Qualifications

• Bachelor's in life sciences; advanced degree preferred.
• Minimum 8 years in regulatory affairs strategy.
• Strong knowledge of FDA/EMA/ICH guidelines and regulations.

Responsibilities

• Provides regulatory strategic direction for global development programs.
• Assists senior staff with development program activities and deliverables.
• Designs regulatory strategies to obtain/maintain INDs, CTAs, NDAs.
• Represents regulatory on early and late-phase clinical studies.
• Collaborates with cross-functional teams to ensure lifecycle compliance.
• Maintains submission plans and health authority communications.
• Tracks major submission deliverables and dependencies.

Skills

Regulatory strategy

FDA/EMA/ICH knowledge

Project management

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in life-sciences

Advanced degree preferred

Tools

MS Project

Smartsheet

Excel

Job description

Nurix Therapeutics, a clinical-stage biopharmaceutical company, seeks a Regulatory leader to help build and execute global regulatory strategy for development and future marketing of products. You will work within the Regulatory team and interact with global authorities to ensure compliant submissions and lifecycle management.

The role requires 8+ years in Regulatory affairs strategy, deep knowledge of FDA/EMA/ICH guidelines, and strong cross-functional collaboration.