Nurix Therapeutics
Senior Director, Regulatory Affairs (Strategy, Hematology Oncology)
Brisbane, California, United States · Director
Sponsorship not specifiedDetected 3 days ago
Project ManagementExcelClinical TrialsPatient CareFDA RegulatoryResearchCommunicationCritical ThinkingRegulatory Affairs
About the role
- Nurix Therapeutics, Inc. is seeking a Senior Director Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.
- This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.
Responsibilities
- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- 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
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- 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
- Manages consultants and contractors as needed
Nice to have
- Bachelor's degree in life-sciences or related scientific discipline
- advanced degree preferred
Skills
- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
- Must have minimum of 12 years in Regulatory affairs strategy
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to comply with changing regulatory
- Strong project management and critical thinking skills
- Excellent organizational and communication skills, both written and verbal
- Positive attitude, energetic and proactive
- Strong interpersonal skills and the ability to effectively work with others
Compensation
- 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
Benefits
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
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