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Sr Manager/AD Regulatory Affairs CMC (small molecules)

Employer
Nurix Therapeutics
Location
San Francisco, CA
Start date
May 25, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details


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

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/). 

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

Company info
Website
Phone
415-660-5320
Location
1700 Owens Street
Suite 205
San Francisco
California
94158
US

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