Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

BioSpace; Brisbane (CA); On-site; USD 188,000 - 231,000; Full time

Job summary

Nurix Therapeutics seeks a Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to help build and execute global regulatory strategy for development and future marketing of products.

You will lead regulatory planning, submissions, and risk management in a fast-paced, collaborative environment, working with FDA/EMA and other health authorities.

Qualifications

• Bachelor’s degree in life-sciences or related field; advanced degree preferred.
• Minimum 8 years in Regulatory affairs strategy.
• Strong knowledge of FDA, EMA and ICH guidelines and regulations.
• Experience preparing regulatory submissions to health authorities across US and global programs.

Responsibilities

• Provides regulatory strategic direction for global development programs.
• Designs and implements regulatory strategies to obtain and maintain INDs, CTAs, NDAs.
• Acts as regulatory representative on clinical studies ensuring compliant execution.
• Prepare and maintain Annual Reports and DSURs.
• Collaborate with cross-functional teams to manage regulatory submissions and risk.

Skills

Regulatory strategy

FDA

EMA

ICH guidelines

Project management

MS Project

Smartsheet

Excel

Cross-functional collaboration

Education

Bachelor's degree in life-sciences

Advanced degree (preferred)

Tools

MS Project

Smartsheet

Excel

Job description

Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

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.

Job Summary

In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.

Responsibilities

• Provides regulatory strategic direction and support for assigned global development programs/development program activities
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
• Assist in the cataloging and maintenance of regulatory application submissions
• Conduct research and stay up-to-date on regulatory requirements and changes
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Oversee quality assurance processes to ensure compliance with regulatory standards
• Review SOPs pertaining to Regulatory
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience And Skills

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 years in Regulatory affairs strategy
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
• Ability to comply with changing regulatory
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

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 Range:

SM $187,800 - $208,638 AD $199,500 - $231,200

Location:

Brisbane, CA - Onsite