Nurix was founded by internationally recognized experts in the ubiquitin-proteasome (UPS) field and received its initial funding from leading life science investors Third Rock Ventures and The Column Group. Nurix recently entered into a multi-year collaboration with Gilead and Sanofi focused on developing bi-functional molecules to degrade protein targets as novel therapeutics. Additionally, Nurix has a strong internal drug discovery pipeline focused on oncology, immunology and inflammation. Nurix plans to advance two molecules into clinical trials in early 2021.
We are seeking to hire a Regulatory Affairs Associate who will support the preparation and maintenance of regulatory submissions to FDA and other Regulatory Agencies. The function will work closely with the CMC, nonclinical, and clinical team members, track and assemble submission components, and build INDs with the regulatory publishing function.
- Responsible for timely planning, coordination, and execution of regulatory submissions
- Conduct regulatory review of submission documents
- Coordinate document workstream with external publishing group
- Represent Regulatory Affairs on cross-functional teams and provide regulatory guidance
- Lead preparation of IND annual reports/DSUR and contribute to authoring
- Prepare IND amendments (e.g. monthly clinical site packages)
- Develop and maintain regulatory knowledge and advise on changing regulatory requirements
- Track commitments from Regulatory Agency submissions and/or Agency Feedback
- Manage and maintain regulatory archive
- Contribute to developing regulatory SOPs
- University degree in science, engineering, and/or biotechnology
- At least 2 years of experience in Regulatory Affairs in the pharmaceutical industry
- Familiar with FDA regulations and FDA/ICH guidelines
- Working knowledge of regulatory compliance for essential clinical site documents.
- Experience with ex-US regulations is a plus
- Meticulous attention to detail
- Ability to self-manage varying workloads across several programs
- Strong interpersonal and communication skills
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.