Sr Manager/AD Regulatory Affairs CMC (small molecules)

Nurix Therapeutics

Nurix Therapeutics

Legal
San Francisco, CA, USA
Posted on Saturday, May 25, 2024

Responsibilities and Duties:

  • Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions
  • Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissions
  • Conduct regulatory review of submission documents
  • Coordinate with external publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with submission standards
  • Represent Regulatory Affairs on cross-functional study teams and provide regulatory guidance
  • Regulatory point of contact for preparation of IND annual reports/DSUR and contribute to authoring
  • Prepare 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 authorities
  • Lead meeting request and briefing book development for some Health Authority (HA) meetings
  • Lead team preparation for some milestone HA meetings
  • Support the selection and onboarding of vendors/CRO’s and provide effective ongoing management to vendors/CRO’s to ensure compliance and execution of deliverables
  • Develop and maintain regulatory knowledge and advise on changing regulatory requirements
  • Track and execute on commitments from Regulatory Agency submissions and/or Agency Feedback
  • Manage the development regulatory SOPs

Required Qualifications:

  • University degree in biology, biochemistry, immunology, microbiology, biotechnology, or similar disciplines
  • Five 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 level
  • Experience working on IND submissions
  • Experience contributing and attending HA meetings
  • Familiar with FDA regulations and FDA/ICH guidelines
  • Working 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 CTAs
  • Meticulous attention to detail
  • Ability to self-manage varying workloads across several programs
  • Strong interpersonal and communication skills

Bonus Qualifications:

  • Understanding of Orphan Drug regulations
  • Experience leading HA interactions

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