Instagram
youtube
Facebook

Manager/Sr Manger/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) - Remote

8+ years
Not Disclosed
10 March 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) – Remote

Company: Initial Therapeutics, Inc. (Nurix Therapeutics)
Location: San Francisco, CA (Remote)
Employment Type: Full-Time

Job Overview:

Nurix Therapeutics, a clinical-stage biopharmaceutical company, is seeking a Manager, Sr. Manager, or Associate Director of Regulatory Affairs (Strategy, Hematology Oncology) to join its Regulatory team. This role is responsible for developing and executing global regulatory strategies, ensuring compliance with regulatory authorities, and supporting clinical development plans. The ideal candidate will collaborate cross-functionally and assist in regulatory submissions, approvals, and lifecycle management.

Key Responsibilities:

Regulatory Strategy & Compliance:

  • Provide regulatory strategic direction for assigned global development programs.
  • Design and implement regulatory strategies for product development, approval, and lifecycle management.
  • Serve as a regulatory representative for early and late-phase clinical studies, ensuring compliance with global regulatory authorities.
  • Monitor regulatory risks and develop mitigation strategies.
  • Stay up to date with FDA, EMA, and ICH guidelines and evolving regulatory landscapes.

Regulatory Submissions & Documentation:

  • Support the preparation, submission, and maintenance of INDs, CTAs, NDAs, DSURs, Investigator’s Brochures, and Annual Reports.
  • Respond to global regulatory authority inquiries and assist in regulatory meetings.
  • Manage and track regulatory application submissions and maintain submission plan templates.
  • Oversee quality assurance processes to ensure regulatory compliance.

Cross-Functional Collaboration & Project Management:

  • Work with cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
  • Participate in regulatory submission planning and execution.
  • Manage consultants and contractors as needed.
  • Contribute to the development and improvement of regulatory submission processes and systems.

Required Qualifications:

  • Education: Bachelor's degree in Life Sciences or a related field (Advanced degree preferred).
  • Experience: Minimum 8 years in Regulatory Affairs strategy, with expertise in hematology-oncology.
  • Strong understanding of FDA, EMA, and ICH guidelines.
  • Experience supporting clinical trial and marketing applications for global regulatory agencies.
  • Strong project management and critical thinking skills.
  • Proficiency in regulatory submission planning tools (e.g., MS Project, Smartsheet, Excel).
  • Excellent organizational, verbal, and written communication skills.

Preferred Qualifications:

  • Proven experience managing major regulatory filings and lifecycle management.
  • Ability to work independently and in a team environment.
  • Strong problem-solving skills with a proactive, positive attitude.
  • Experience managing regulatory consultants and contractors.

Join Nurix Therapeutics and be part of a cutting-edge biopharmaceutical team shaping the future of targeted protein degradation therapies!