Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)

BioSpace; Brisbane (CA); Sur place; USD 188 000 - 209 000; Plein temps

Résumé du poste

Nurix Therapeutics seeks an experienced CMC Regulatory professional to shape global regulatory strategies and lead Module 3 content across small molecule programs. You will influence cross-functional teams, own submission timelines, and mentor junior staff, with Senior Associate Director level growth and strategic ownership.

You will author and review CMC Module 3 content for IND/IMPD filings, assess changes affecting regulatory filings, and ensure compliance with ICH, FDA, EMA requirements

Qualifications

• Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or related life sciences required.
• Minimum 6+ years in regulatory affairs with substantial focus on CMC and 10+ years total pharma/biotech experience.
• Experience authoring/compiling CMC (Module 3) content for regulatory submissions for small molecule products.

Responsabilités

• Develop, communicate, and execute global CMC regulatory strategies for drug substance and drug product across product lifecycle.
• Author, review, and compile high-quality CMC Module 3 content for regulatory submissions (IND/IMPD and global filings).
• Assess regulatory impact of manufacturing, analytical, formulation, and supply chain changes; recommend filing strategies.
• Provide proactive CMC regulatory guidance and risk assessment to development, ops, and commercial teams.
• Represent CMC Regulatory on cross-functional teams; manage submission timelines and deliverables.
• Ensure submission content is accurate, consistent, and compliant with ICH, FDA, EMA and other markets.
• Oversee QA processes to ensure regulatory standards; mentor junior staff where applicable.

Connaissances

CMC regulatory strategies

Regulatory submissions

Module 3 content authoring

Cross-functional collaboration

Regulatory guidance

Mentoring junior staff

Formation

Bachelor's degree in life sciences

Advanced degree preferred (MS/PhD/PharmD)

Description du poste

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.

Position Description

The Opportunity

• Report to the Senior Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecules) as a key member of the Regulatory Affairs team
• Develop, communicate, and execute global CMC regulatory strategies for assigned programs (drug substance and drug product) across the product lifecycle
• 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

What You'll Bring

• Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or a related life sciences field is required; an advanced degree (M.S., Ph.D., or Pharm.D.) is preferred
• Minimum 6+ years in regulatory affairs with a substantial focus on CMC, and 10+ years of overall pharmaceutical/biotech industry experience
• Demonstrated experience authoring and/or compiling CMC (Module 3) content for regulatory submissions for small molecule products
• Working knowledge of ICH quality guidelines and of FDA and/or EMA CMC requirements; familiarity with other global regions is a plus
• Solid understanding of pharmaceutical development, manufacturing processes, and analytical methods for small molecules
• Strong written communication and scientific/technical writing skills
• Ability to manage multiple projects and competing timelines with attention to detail
• Effective cross-functional collaboration and stakeholder management
• Comfort operating with autonomy while escalating appropriately

Salary Range: $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.

Location: Onsite - Brisbane, CA

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

About Nurix Therapeutics

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.