layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) at Nurix Therapeutics | LAYIQ

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

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

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