Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)
Nurix Therapeutics
August 24, 2026
On-site
Brisbane, CA
Corporate Functions
Responsibilities:
- Develop and execute a comprehensive global regulatory strategy to drive product development, global registration, desired regional labeling, and effective agency interactions.
- Identify regulatory risks and mitigation strategies.
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead and manage preparation of high-quality global submissions (IND, CTAs, NDAs, MAAs) for early- and late-stage programs in collaboration with teams.
- Plan and prepare for formal regulatory agency meetings; communicate with global Health Authorities (e.g., FDA, EMA) and interpret feedback.
- Develop and execute/oversee long-term regulatory strategy, including potential expedited development needs.
- Provide guidance on implementation of current regulations; assess regulatory risk based on precedence.
- Ensure adherence to applicable regulations and company SOPs.
- Create actionable submission plans; track major deliverables and dependencies; ensure consistent management of submission documents and health authority communications.
- Define requirements and support future systems/tools for document management, submission planning, and regulatory information management.
- Develop and maintain submission plan templates; participate in cross-functional initiatives impacting submission processes/systems.
- Manage consultants and contractors as needed.
Qualifications/Skills:
- Bachelor’s in life sciences or related discipline; advanced degree preferred.
- 12+ years in regulatory affairs strategy with significant oncology (solid tumors) experience.
- Strong knowledge of drug development and FDA, EMA, and ICH guidelines/regulations.
- Hands-on experience planning clinical trial and marketing applications for Health Authorities.
- Track record supporting major filings and ongoing maintenance of clinical trial/marketing applications.
- Strong project management and critical thinking; experience with tools/techniques (e.g., Veeva RIM, Smartsheet, Excel trackers).
- Excellent written/verbal communication; strong organization; ability to work independently and collaboratively.
- Proactive, positive, able to manage multiple projects and resolve regulatory issues.
Location: Brisbane, CA (Onsite).
- Develop and execute a comprehensive global regulatory strategy to drive product development, global registration, desired regional labeling, and effective agency interactions.
- Identify regulatory risks and mitigation strategies.
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead and manage preparation of high-quality global submissions (IND, CTAs, NDAs, MAAs) for early- and late-stage programs in collaboration with teams.
- Plan and prepare for formal regulatory agency meetings; communicate with global Health Authorities (e.g., FDA, EMA) and interpret feedback.
- Develop and execute/oversee long-term regulatory strategy, including potential expedited development needs.
- Provide guidance on implementation of current regulations; assess regulatory risk based on precedence.
- Ensure adherence to applicable regulations and company SOPs.
- Create actionable submission plans; track major deliverables and dependencies; ensure consistent management of submission documents and health authority communications.
- Define requirements and support future systems/tools for document management, submission planning, and regulatory information management.
- Develop and maintain submission plan templates; participate in cross-functional initiatives impacting submission processes/systems.
- Manage consultants and contractors as needed.
Qualifications/Skills:
- Bachelor’s in life sciences or related discipline; advanced degree preferred.
- 12+ years in regulatory affairs strategy with significant oncology (solid tumors) experience.
- Strong knowledge of drug development and FDA, EMA, and ICH guidelines/regulations.
- Hands-on experience planning clinical trial and marketing applications for Health Authorities.
- Track record supporting major filings and ongoing maintenance of clinical trial/marketing applications.
- Strong project management and critical thinking; experience with tools/techniques (e.g., Veeva RIM, Smartsheet, Excel trackers).
- Excellent written/verbal communication; strong organization; ability to work independently and collaboratively.
- Proactive, positive, able to manage multiple projects and resolve regulatory issues.
Location: Brisbane, CA (Onsite).