Director, Regulatory Affairs ~ Strategy, Immunology and Inflammation
Nurix Therapeutics
August 20, 2026
On-site
Brisbane, CA
Corporate Functions
Responsibilities:
- Develop and implement global clinical & nonclinical regulatory strategies for immunology and inflammation indications; identify risks and mitigation strategies.
- Collaborate with Regulatory leadership, development team leaders, cross-functional partners, and CROs to deliver development strategies and operational plans.
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead development and preparation of high-quality global submissions (IND, CTAs, NDAs, MAAs) for early and late-stage programs.
- Lead communication with global Health Authorities (e.g., FDA, EMA), including planning/preparing for meetings and interpreting feedback.
- Develop and execute long-term regulatory strategy, including accommodating expedited development needs.
- Anticipate issues; guide risk mitigation and assess regulatory risk based on precedence.
- Ensure adherence to current regulations and applicable company SOPs.
- Build detailed, actionable submission plans; track deliverables and ensure consistent submission documents and regulatory communications.
- Define requirements for and support future systems/tools for document management, submission planning, and regulatory information management.
- Track major submission deliverables and dependencies; develop and maintain submission plan templates.
- Participate in cross-functional process initiatives; manage consultants/contractors as needed.
Requirements:
- Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
- Minimum 12 years in Regulatory affairs strategy with significant immunology and inflammation experience.
- Strong knowledge of drug development, FDA/EMA, and ICH guidelines/regulations.
- Hands-on experience supporting planning of clinical trials and marketing applications.
- Proven record supporting major filings and maintenance of clinical trial/marketing applications.
- Strong project management/critical thinking; experience with MS Project, Smartsheet, and Excel trackers.
- Excellent written/verbal communication, organization, and interpersonal skills; able to work independently and in teams.
- Proactive, energetic; able to manage multiple projects and resolve regulatory issues.
Salary Range: 220K – 254K plus bonus and equity.
- Develop and implement global clinical & nonclinical regulatory strategies for immunology and inflammation indications; identify risks and mitigation strategies.
- Collaborate with Regulatory leadership, development team leaders, cross-functional partners, and CROs to deliver development strategies and operational plans.
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead development and preparation of high-quality global submissions (IND, CTAs, NDAs, MAAs) for early and late-stage programs.
- Lead communication with global Health Authorities (e.g., FDA, EMA), including planning/preparing for meetings and interpreting feedback.
- Develop and execute long-term regulatory strategy, including accommodating expedited development needs.
- Anticipate issues; guide risk mitigation and assess regulatory risk based on precedence.
- Ensure adherence to current regulations and applicable company SOPs.
- Build detailed, actionable submission plans; track deliverables and ensure consistent submission documents and regulatory communications.
- Define requirements for and support future systems/tools for document management, submission planning, and regulatory information management.
- Track major submission deliverables and dependencies; develop and maintain submission plan templates.
- Participate in cross-functional process initiatives; manage consultants/contractors as needed.
Requirements:
- Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
- Minimum 12 years in Regulatory affairs strategy with significant immunology and inflammation experience.
- Strong knowledge of drug development, FDA/EMA, and ICH guidelines/regulations.
- Hands-on experience supporting planning of clinical trials and marketing applications.
- Proven record supporting major filings and maintenance of clinical trial/marketing applications.
- Strong project management/critical thinking; experience with MS Project, Smartsheet, and Excel trackers.
- Excellent written/verbal communication, organization, and interpersonal skills; able to work independently and in teams.
- Proactive, energetic; able to manage multiple projects and resolve regulatory issues.
Salary Range: 220K – 254K plus bonus and equity.