Nurix, Inc.
Sr Manager/AD Regulatory Affairs CMC (small molecules)
Nurix, Inc., San Francisco, California, United States, 94199
Responsibilities
and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with submission standardsRepresent Regulatory Affairs on cross-functional study teams and provide regulatory guidanceRegulatory point of contact for preparation of IND annual reports/DSUR and contribute to authoringPrepare and review IND amendments (e.g. monthly clinical site packages)Responsible for compliant regulatory archives by logging, tracking, and filing of submissions and correspondence with regulatory authoritiesLead meeting request and briefing book development for some Health Authority (HA) meetingsLead team preparation for some milestone HA meetingsSupport the selection and onboarding of vendors/CRO's and provide effective ongoing management to vendors/CRO's to ensure compliance and execution of deliverablesDevelop and maintain regulatory knowledge and advise on changing regulatory requirementsTrack and execute on commitments from Regulatory Agency submissions and/or Agency FeedbackManage the development regulatory SOPsRequired Qualifications:
University degree in biology, biochemistry, immunology, microbiology, biotechnology, or similar disciplinesFive to eight or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Senior Manager level; Eight to ten or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Associate Director levelExperience working on IND submissionsExperience contributing and attending HA meetingsFamiliar with FDA regulations and FDA/ICH guidelinesWorking knowledge of regulatory compliance for essential clinical site documents and proven practical experience in preparing investigator information for FDA submission.Experience with ex-US regulations and practical experience in preparing CTAsMeticulous attention to detailAbility to self-manage varying workloads across several programsStrong interpersonal and communication skillsBonus Qualifications:
Understanding of Orphan Drug regulationsExperience leading HA interactions
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/).
and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with submission standardsRepresent Regulatory Affairs on cross-functional study teams and provide regulatory guidanceRegulatory point of contact for preparation of IND annual reports/DSUR and contribute to authoringPrepare and review IND amendments (e.g. monthly clinical site packages)Responsible for compliant regulatory archives by logging, tracking, and filing of submissions and correspondence with regulatory authoritiesLead meeting request and briefing book development for some Health Authority (HA) meetingsLead team preparation for some milestone HA meetingsSupport the selection and onboarding of vendors/CRO's and provide effective ongoing management to vendors/CRO's to ensure compliance and execution of deliverablesDevelop and maintain regulatory knowledge and advise on changing regulatory requirementsTrack and execute on commitments from Regulatory Agency submissions and/or Agency FeedbackManage the development regulatory SOPsRequired Qualifications:
University degree in biology, biochemistry, immunology, microbiology, biotechnology, or similar disciplinesFive to eight or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Senior Manager level; Eight to ten or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Associate Director levelExperience working on IND submissionsExperience contributing and attending HA meetingsFamiliar with FDA regulations and FDA/ICH guidelinesWorking knowledge of regulatory compliance for essential clinical site documents and proven practical experience in preparing investigator information for FDA submission.Experience with ex-US regulations and practical experience in preparing CTAsMeticulous attention to detailAbility to self-manage varying workloads across several programsStrong interpersonal and communication skillsBonus Qualifications:
Understanding of Orphan Drug regulationsExperience leading HA interactions
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/).