Director, Regulatory Affairs

Redmond, WA

Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.

Major Responsibilities

  • Provides strong regulatory guidance and support to assigned clinical development project teams in the development plan and implementation of regulatory strategy to maximize probability of regulatory success.
  • Leads and/or participates in the formulation and implementation of project regulatory strategy.
  • Identifies potential regulatory risks to the strategy/operations plan and propose risk mitigation options.
  • Provides regulatory review and approve of clinical trial documents (e.g. trial protocols and reports, investigator brochures and regulatory submission packages, etc.) to ensure regulatory compliance.
  • Serves as primary contact with FDA and other Regulatory Agencies, including preparing meeting and communications, to promote accelerated approval of original applications and supplements.
  • Explains and communicates regulatory expectations to internal teams and external CRO to implement planned objectives in accordance with applicable regulations.
  • Maintains current awareness of regulatory knowledge or new requirements across oncology areas and develops regulatory intelligence.
  • Assists to develop regulatory strategy and update strategy according to regulatory change.
  • Provides support for responding to regulatory authorities questions and prepares meetings with regulatory agencies.
  • Willingness and ability to travel domestically and internationally, particularly China, as required (up to 25%).

Qualifications:

  • MS or PhD degree in a scientific or medical discipline with a minimum of 15 years in regulatory affairs management and 10 years in a leadership role.
  • Strong understanding of US and global regulations as they apply to pharmaceutical drug development.
  • Demonstrates successful experience in the preparation and submission of INDs, BLAs, NDAs and other global clinical trial application development.
  • Proven ability to plan and execute complex projects.
  • Experience in directing interaction/negotiation regulatory agency (e.g. FDA) interactions and meetings.
  • Proven ability to collaborate across departments and with outside investigators and CROs.
  • Excellent written and verbal communication skills.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]

Systimmune offers a flexible schedule, competitive salary, and generous benefits package including a health/dental/vision care package, employer retirement match, and paid time off!
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