Senior Associate, Regulatory Operations
Scorpion Therapeutics, Brisbane, CA, United States
Overview
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. 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 (BTK), and an inhibitor of CBL-B, an E3 ligase that regulates T cell activation. Nurix is progressing multiple programs through partnership, including an IRAK4 degrader in Phase 1 in partnership with Gilead and a STAT6 degrader in IND enabling studies with Sanofi. Multiple additional wholly owned and partnered programs are at various stages of preclinical development.
Position Reporting to the Director, Regulatory Affairs Project Management and Operations, the Senior Associate, Regulatory Operations provides key support to the Nurix Regulatory Affairs department. This position has responsibility for entry-level coordination, review, assembly and archival of regulatory submissions in Veeva RIMS and documents for health authorities (US FDA and global equivalents). The Senior Associate, Regulatory Operations will provide support for multiple regulatory activities, studies, and programs. The individual will have responsibility to understand and implement regulatory guidance and help ensure regulatory compliance for assigned projects. The Senior Associate should have 2–3 years’ experience in Regulatory Affairs or Regulatory Operations. Working knowledge of at least one functional discipline (e.g. Regulatory, Clinical, Nonclinical, Clinical Pharmacology or Chemistry Manufacturing and Controls) and a general knowledge of clinical development preferred. The candidate should have a can-do attitude and experience working in Veeva RIMS. Also, the candidate should be eager to learn regulatory and clinical trial requirements, best practices, and provide support for Regulatory programs and leadership.
Responsibilities
Under the strategic direction of the SVP of Regulatory Affairs and the Director of Regulatory Affairs PM and Operations, the candidate will support the planning, coordination, tracking and execution of submissions and responses to global regulatory authorities
Assist Regulatory team, project teams and Clinical Research Organization (CRO) counterparts in the implementation of regulatory plans, timely delivery, and submission of regulatory documentation
Preparation of Regulatory submission documentation (e.g Forms, Cover Letter) as requested
Support team with formatting, QC and publishing of submission documents and packages
Manage and support Veeva RIMS processes such as HAI, SCP and Archiving
Manage authoring and review workflow in Veeva RIMS according to defined timelines
Coordinate with regulatory colleagues and cross-functional departments to prepare, compile, review, and submit documents or information necessary to health authorities in accordance with regulations, guidelines or queries in Veeva RIMS using SCP
Maintain archival copies of health authority submissions (e.g., IND, CTA, NDA, and MAA), correspondence and a record of health authority obligations, and commitments
Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration. Participate in Regulatory Intelligence activities to help inform team members of new applicable guidelines and conduct training sessions on new guidelines/regulations if necessary
Participate in kick-off and project-based meetings related to regulatory submissions, strategy, and comment resolution. Be a reliable resource for information following such meetings
Follow general instructions from Regulatory management or company leadership for assigned projects while independently planning daily work tasks to complete projects on time. Seek guidance on project/task priorities as needed
Communicate important project decisions or challenges to Regulatory leadership
Create or contribute to Standard Operating Procedures (SOP), checklists and training Materials for Regulatory department activities
Support contracts and Purchase order for the Regulatory Affairs department
Qualifications
Bachelor's Degree in Life Sciences or relevant field
Minimum of 4-5 years’ experience working in Regulatory Affairs or Regulatory Operations; additional experience in the biotechnology or pharmaceutical industry preferred
Understanding of the drug development process
Proficient knowledge of Veeva RIMS SCP, workflows, archival, reporting…
Experienced publisher (DocuBridge, GlobalSubmit, VeevaVault Submission…)
Experience successfully supporting critical deliverables while maintaining agreed timelines
Demonstrated ability to work effectively with cross-functional teams or collaborative environments
Basic knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines
Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus
Previous experience with maintaining in-house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva) is a plus
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
Superior communication skills: oral, written, with proven negotiation skills, and strong time-management
Excellent computer skills: MS Word, Excel, PowerPoint, Smartsheet and document management software/system, templates
Ability to work on multiple tasks and prioritize to meet company objectives. Strong attention to detail and time management skills are essential
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
Salary and Location Salary Range: 140K - 160K plus bonus & equity.
Location: Brisbane, CA (Onsite role)
#J-18808-Ljbffr
Position Reporting to the Director, Regulatory Affairs Project Management and Operations, the Senior Associate, Regulatory Operations provides key support to the Nurix Regulatory Affairs department. This position has responsibility for entry-level coordination, review, assembly and archival of regulatory submissions in Veeva RIMS and documents for health authorities (US FDA and global equivalents). The Senior Associate, Regulatory Operations will provide support for multiple regulatory activities, studies, and programs. The individual will have responsibility to understand and implement regulatory guidance and help ensure regulatory compliance for assigned projects. The Senior Associate should have 2–3 years’ experience in Regulatory Affairs or Regulatory Operations. Working knowledge of at least one functional discipline (e.g. Regulatory, Clinical, Nonclinical, Clinical Pharmacology or Chemistry Manufacturing and Controls) and a general knowledge of clinical development preferred. The candidate should have a can-do attitude and experience working in Veeva RIMS. Also, the candidate should be eager to learn regulatory and clinical trial requirements, best practices, and provide support for Regulatory programs and leadership.
Responsibilities
Under the strategic direction of the SVP of Regulatory Affairs and the Director of Regulatory Affairs PM and Operations, the candidate will support the planning, coordination, tracking and execution of submissions and responses to global regulatory authorities
Assist Regulatory team, project teams and Clinical Research Organization (CRO) counterparts in the implementation of regulatory plans, timely delivery, and submission of regulatory documentation
Preparation of Regulatory submission documentation (e.g Forms, Cover Letter) as requested
Support team with formatting, QC and publishing of submission documents and packages
Manage and support Veeva RIMS processes such as HAI, SCP and Archiving
Manage authoring and review workflow in Veeva RIMS according to defined timelines
Coordinate with regulatory colleagues and cross-functional departments to prepare, compile, review, and submit documents or information necessary to health authorities in accordance with regulations, guidelines or queries in Veeva RIMS using SCP
Maintain archival copies of health authority submissions (e.g., IND, CTA, NDA, and MAA), correspondence and a record of health authority obligations, and commitments
Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration. Participate in Regulatory Intelligence activities to help inform team members of new applicable guidelines and conduct training sessions on new guidelines/regulations if necessary
Participate in kick-off and project-based meetings related to regulatory submissions, strategy, and comment resolution. Be a reliable resource for information following such meetings
Follow general instructions from Regulatory management or company leadership for assigned projects while independently planning daily work tasks to complete projects on time. Seek guidance on project/task priorities as needed
Communicate important project decisions or challenges to Regulatory leadership
Create or contribute to Standard Operating Procedures (SOP), checklists and training Materials for Regulatory department activities
Support contracts and Purchase order for the Regulatory Affairs department
Qualifications
Bachelor's Degree in Life Sciences or relevant field
Minimum of 4-5 years’ experience working in Regulatory Affairs or Regulatory Operations; additional experience in the biotechnology or pharmaceutical industry preferred
Understanding of the drug development process
Proficient knowledge of Veeva RIMS SCP, workflows, archival, reporting…
Experienced publisher (DocuBridge, GlobalSubmit, VeevaVault Submission…)
Experience successfully supporting critical deliverables while maintaining agreed timelines
Demonstrated ability to work effectively with cross-functional teams or collaborative environments
Basic knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines
Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus
Previous experience with maintaining in-house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva) is a plus
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
Superior communication skills: oral, written, with proven negotiation skills, and strong time-management
Excellent computer skills: MS Word, Excel, PowerPoint, Smartsheet and document management software/system, templates
Ability to work on multiple tasks and prioritize to meet company objectives. Strong attention to detail and time management skills are essential
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
Salary and Location Salary Range: 140K - 160K plus bonus & equity.
Location: Brisbane, CA (Onsite role)
#J-18808-Ljbffr