Nurix, Inc.
Director/Sr. Director, Regulatory Affairs (Strategy, Immunology and Inflammation
Nurix, Inc., San Francisco, California, United States, 94199
Job Summary:
Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.
This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.
Responsibilities:Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategiesWork in close collaboration with the VP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plansRepresent Regulatory Affairs on assigned cross-functional development teams.Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicableLead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needsAnticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedenceEnsure adherence to current regulations associated with regulatory activitiesWorks 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 applicationsPlays 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 managementTracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependenciesDevelops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programsParticipates in cross-functional process initiatives impacting regulatory submission processes and systemsManages consultants and contractors as neededExperience and Skills:
Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic areaStrong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulationsExperience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMAProven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applicationsStrong project management and critical thinking skillsExperience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissionsExcellent organizational and communication skills, both written and verbalAbility to work independently as well as part of a team environmentPositive attitude, energetic and proactiveProven ability to manage multiple projects, identify and resolve regulatory issuesStrong interpersonal skills and the ability to effectively work with others
Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).
Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.
This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.
Responsibilities:Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategiesWork in close collaboration with the VP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plansRepresent Regulatory Affairs on assigned cross-functional development teams.Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicableLead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needsAnticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedenceEnsure adherence to current regulations associated with regulatory activitiesWorks 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 applicationsPlays 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 managementTracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependenciesDevelops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programsParticipates in cross-functional process initiatives impacting regulatory submission processes and systemsManages consultants and contractors as neededExperience and Skills:
Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic areaStrong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulationsExperience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMAProven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applicationsStrong project management and critical thinking skillsExperience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissionsExcellent organizational and communication skills, both written and verbalAbility to work independently as well as part of a team environmentPositive attitude, energetic and proactiveProven ability to manage multiple projects, identify and resolve regulatory issuesStrong interpersonal skills and the ability to effectively work with others
Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).