Nurix Therapeutics is seeking an Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team. The successful candidate will be responsible for helping build and execute on global regulatory strategy, objectives, policies, and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high-quality, nonclinical, and clinical submissions and interactions in support of early development, registration, and life cycle management activities.
Requirements
- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
- Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assist in the cataloging and maintenance of regulatory application submissions
- Conduct research and stay up-to-date on regulatory requirements and changes
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- Oversee quality assurance processes to ensure compliance with regulatory standards
- Review SOPs pertaining to Regulatory
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed
Benefits
- Comprehensive health benefits
- 401(k) plan
- Stock option
- Relocation assistance
