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Brisbane, California
Source: Nurix Therapeutics careers · View original posting
From Nurix Therapeutics's posting. “We” and “our” refer to the employer.
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)
Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff.
Author, review, and compile high-quality CMC (Module 3 / Quality) content for regulatory submissions, including IND/IMPD and equivalent global filings, amendments, annual reports, and responses to health authority questions
Assess the regulatory impact of manufacturing, analytical, formulation, and supply chain changes, and recommend filing strategies and categorization (e.g., substantial, non-substantial, annual reportable)
Provide proactive CMC regulatory guidance and risk assessment to development, technical operations, and commercial teams
Partner with Technical Operations/Manufacturing, Analytical Development, Quality Control, Quality Assurance, Supply Chain, and CMOs/CDMOs (where applicable) to align technical activities with regulatory requirements
Represent CMC Regulatory on project and CMC sub-teams, and manage submission timelines and deliverables in coordination with regulatory operations and publishing
Ensure submission content is accurate, consistent, scientifically sound, and compliant with ICH guidelines and regional requirements (FDA, EMA, and other markets relevant to the portfolio)
Contribute to regulatory intelligence by monitoring evolving guidance and precedent and translating it into practical advice
Oversee quality assurance processes to ensure compliance with regulatory standards, and participate in cross-functional initiatives that improve regulatory submission processes and systems
At the Associate Director level, take greater strategic ownership and, where applicable, provide line management or mentoring of junior regulatory staff
Compensation
$187,800 - $208,600
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.
Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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