Sr Director, Regulatory Affairs

Job Juncture Manhattan, NY
director regulatory regulatory oncology lead regulations team stakeholders strategy r&d director communications ndas
December 1, 2022
Job Juncture
Manhattan, NY
OTHER

My client is expanding and seeks a Sr Director, Regulatory Affairs focused in immuno-oncology to take on the following tasks:

  • Lead regulatory agency interactions, communications, and submissions including INDs, NDAs, and BLAs.
  • Provide regulatory strategies, tactical guidance, and overall strategic planning based on applicable regulations and guidance.
  • Ensure project team and key stakeholders are apprised of developments that may impact regulatory success.
  • Anticipate risks and be responsible for developing solutions to identified risks and discussing with key stakeholders.
  • Lead FDA meetings and work with all relevant parties to ensure successful outcomes.
  • Identify and interpret regulations, guidelines, and other information issued by regulatory agencies and others.

 

The ideal candidate will possess the following qualities:

  • BA/BS and strong experience in hematology or oncology regulatory affairs.
  • 8+ years of experience in clinical R&D focused on regulatory affairs with expertise from IND-submission to post-approval Phase 4 studies.
  • Extensive knowledge of clinical and product development life cycles for investigational and marketed products.
  • Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international.
  • Experience in authoring, reviewing and submitting all key components of regulatory submissions (orphan, fast track, breakthrough, NDA, BLA, etc).
  • Comprehensive knowledge of GCP, GMP, and Quality Systems Management including ISO 13485.
  • Strong understanding and interpretation of complex scientific issues across multiple programs as it relates to regulatory requirements and strategy for assigned programs and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.


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