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

The role

This person will help build and execute global regulatory strategy, objectives, policies, and programs for product development and marketing. They will provide strategic direction for assigned global development programs and support regulatory activities.

What you will do

• Provides regulatory strategic direction and support for assigned global development programs
• Assists Sr. Regulatory Affairs staff with development program activities and deliverables
• Designs and implements regulatory strategies to obtain and maintain product applications
• Acts as regulatory representative on early and/or late phase clinical studies
• Responds to inquiries from global regulatory authorities and conducts meetings
• Assists in the preparation and maintenance of regulatory documents like Annual Reports, DSURs, and Investigator’s Brochures
• Assists in the cataloging and maintenance of regulatory application submissions
• Conducts research on regulatory requirements and changes
• Collaborates with cross-functional teams to ensure product compliance
• Monitors and assesses regulatory risks and develops mitigation strategies

Required qualifications

• Bachelor's degree in life-sciences or related scientific discipline
• Minimum of 8 years in Regulatory affairs strategy for Manager role
• 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 FDA and EMA
• Ability to read, analyze and interpret scientific, technical and regulatory information
• Ability to explain detailed regulatory affairs and compliance programs to senior management or external parties
• Ability to comply with changing regulatory
• Track record of supporting Regulatory affairs in planning and execution of major filings and maintenance of applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools like MS Project, Smartsheet, or Excel trackers
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently and as part of a team

Nice to have

• advanced degree

About the company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. The company aims to establish degrader-based treatments at the forefront of patient care.