Director, Regulatory Affairs

REG AFFAIRS · Santa Ana, California
Department REG AFFAIRS
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

Job Title
Director, Regulatory Affairs

 

Job Summary

 

NKGen Biotech, Inc. is seeking an experienced individual to fulfill the role of Director, Regulatory Affairs.  The successful candidate will be responsible for developing, leading, and implementing regulatory strategies for NKGen Biotech’s cell therapy products.  The position will focus on clinical and nonclinical aspects of regulatory affairs.  Duties for this position include managing, coordinating, and authoring regulatory submissions to global regulatory authorities.  The Director, Regulatory Affairs will contribute to the development and implementation of best practices (departmental processes, standards, electronic document systems, etc.) as necessary.

The Director, Regulatory Affairs is also accountable for the oversight of external Regulatory Affairs vendors and resources to ensure the timely delivery of high-quality submissions.

 

General Responsibilities

 

  • Lead interdisciplinary regulatory team in establishing regulatory strategy for early-stage development programs.  Regularly reports to management on progress against the company’s goals and objectives.
  • Oversee and manage the planning, preparation, and submission of regulatory applications (IND, CTA, BLA, etc.), including authorship of key regulatory documents.  Ensure submissions are compliant with applicable regulations.  Manage regulatory submission timelines.
  • Serve as the primary interface with FDA and other regulatory authorities as needed.  Lead the preparation of FDA meeting documents, meeting requests, meeting information package, etc.
  • Provide strategic regulatory insight to the core nonclinical and clinical development teams regarding product development.
  • Perform regulatory intelligence and monitor the impact of new regulations.
  • Provides motivation to regulatory personnel through training and mentorship.
  • Perform other duties as assigned.

*The company reserves the right to add or change duties at any time.

 

Job Qualifications & Skills

 

  • MS degree or higher in a scientific field with a minimum of 8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis, or BS degree with 12 years of experience.
  • Prior experience in managing regulatory submissions with the ability to successfully manage projects to deadlines.  Successful track record of filing of INDs/CTAs, NDAs/BLAs/MAAs, meeting requests/meeting informational package, and other pertinent regulatory documents.
  • Prior experience in a product development role; experience with cell therapy product is desirable.
  • History of achieving regulatory goals in ambiguous and challenging situations.
  • Proven ability to successfully interact with regulatory authorities.
  • Proven ability to manage critical projects as a part of an interdisciplinary team.
  • Thorough understanding of relevant drug development regulations and guidelines.  Knowledgeable regarding IND/CTA and marketing application requirements.
  • Strong knowledge of electronic document and submission standards.  Experienced in eCTD publishing.
  • Detailed oriented with outstanding interpersonal and communication (written and verbal) skills.
  • Strong organizational skill

 

Benefits & Perks

 

  • Competitive compensation
  • Medical, Dental and Vision Insurance
  • Business casual work attire
  • Fully stocked kitchen and much more!

Thank You

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  • Location
    Santa Ana, California
  • Department
    REG AFFAIRS
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor