Regulatory Affairs Director – Remote

This late-stage biotechnology company is developing first-in-class T Cell based cancer immunotherapies.  They are seeking a Regulatory Affairs Director (or AD) who can develop and execute on regulatory strategies for their programs in development and lead regulatory submissions.  You will work closely with cross-functional teams and interact directly with US health authorities.  This is a remote role! With their lead candidate in Phase 3, this company offers innovative science, competitive compensation and a patient-focused company culture. Now is an exciting time to join this innovative organization and improve the lives of patients in need!

Responsibilities:

  • Provide regulatory strategy and execution for a portfolio of immune-oncology programs in development.
  • Work closely with functional leaders to 1) create the optimal development path for product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
  • Plan, manage and create regulatory submissions including INDs, BLAs, CTAs, etc.
  • Ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
  • Leads cross-functional teams in preparing for health authority meetings, including pre-IND, pre-BLA and Type C meetings.
  • Provide regulatory advice to cross-functional teams to achieve timely and efficient regulatory submissions while ensuring compliance with applicable regulatory requirements.
  • Effectively plan and prioritize regulatory activities in close collaboration with leads from other functional areas.
  • Ensure that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
  • Work within the department and with other functional areas on process improvements.

 

Required Qualifications:

  • Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
  • 10 or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
  • Direct experience in preparing major drug applications (NDA, BLA, NDS, MAA, etc) required.
  • Prior oncology and/or Immune-oncology experience required. Late stage oncology experience highly desired.
  • Regulatory experience with pre-clinical and clinical drug development, along with lifecycle maintenance and compliance.
  • Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs.
  • Solid working knowledge of FDA requirements. Ex-US experience a plus.
  • Experience interfacing directly with FDA including meeting preparation.
  • Strong organizational and planning skills.
  • Proven ability to communicate effectively and efficiently cross functionally and with regulatory agencies.
  • Ability to build positive relationships with co-workers of various backgrounds and expertise.
  • Outstanding written and verbal communication skills.
  • Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
  • Must be comfortable with ambiguity within an evolving company.

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