ManagerSr ManagerAssociate Director Regulatory Affairs Strategy Hematology Oncology
ManagerSr ManagerAssociate Director Regulatory Affairs Strategy Hematology Oncology
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Job Description
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 AIintegrated discovery engine capable of tackling any protein class and coupled with unparalleled ligase expertise Nurixs dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degraderbased treatments at the forefront of patient care writing medicines next chapter with a new script to outmatch disease.
Job Summary:
Nurix Therapeutics Inc. is seeking a Manager/Sr. Manager/Associate Director Regulatory Affairs (Strategy Hematology Oncology) to join the Regulatory team. The successful candidate 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 for guiding and executing upon regulatory strategy of compliant high quality nonclinical and clinical submissions and interactions in support of early development registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies working crossfunctionally across the organization.
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 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) Investigators 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 uptodate on regulatory requirements and changes
- Collaborate with crossfunctional 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 Nurixs 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 crossfunctional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed
Experience and Skills:
- Bachelors degree in lifesciences 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 handson 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 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 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
Nurix Therapeutics Inc. is committed to protecting and respecting your privacy and personal information including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix you agree to our collection and use of personal information as described in our Privacy Policy Experience:
Director
Employment Type
Full Time
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