VP, Regulatory Affairs

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


Job Title
Vice President, Head of Regulatory Affairs


Job Summary


NKGen Biotech, Inc. is seeking a highly experienced and enthusiastic Regulatory Affairs professional to fulfill the role of Vice President, Head of Regulatory Affairs.  The successful candidate will be accountable for providing strategic regulatory expertise to the Executive team, driving regulatory strategy for overall development of NKGen Biotech’s cell therapies products, and participating in the development and generation of regulatory submissions to regulatory agencies worldwide.  The incumbent will oversee all aspects of regulatory activities not limited to preclinical, clinical and manufacturing development, and ensure regulatory compliance with applicable laws, regulations (state, federal, and international), and company policies that govern the development of the company’s products.


Candidates applying to this role must possess thorough knowledge of U.S. Federal Regulations related to GLP, GCP, and GMP.  Candidates must have substantial experience in all aspects of regulatory affairs, with a track record of successful engagements with regulatory authorities, submissions, and marketing authorization(s) with CDER/CBER.


****Candidates must be based in Southern California or willing to relocate for the position.


General Responsibilities


  • Provide direct oversight of the Regulatory Affairs function.  Manage the department’s responsibilities and priorities.
  • Serve as the regulatory subject matter expert to the company.  Provide strategic regulatory oversight and guidance to the Executive and product development teams.  Advise on regulatory strategies to expedite the development of products.
  • Plan and maintain the company’s regulatory applications.  Spearhead the creation of regulatory applications (IND, CTA, and BLA), including authorship of key regulatory documents, as necessary.  Ensure submissions are compliant with applicable regulations.
  • Review and provide oversight of all critical regulatory submissions.
  • Serve as primary interface with FDA and other regulatory authorities for high impact topics.
  • Perform regulatory risk assessment review to ensure compliance with applicable laws and regulations.
  • Provides motivation to regulatory personnel through training and mentorship.
  • Reviews all planning, budgeting, staffing, and prioritization for the department.
  • Maintain positive work environment with colleagues and external partners.


*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 15 to 20 years of progressive experience in Regulatory Affairs in the biotechnology or pharmaceutical industry.
  • Prior experience in management or leadership roles.
  • Prior experience in oncology drug development.  Experience in immune-oncology and cell therapy is desirable.
  • Prior hands-on experience and knowledge in authoring, compiling, reviewing, and managing major regulatory submissions (INDs/CTAs, NDAs/BLAs/MAAs).
  • Thorough understanding of relevant drug development regulations and guidelines.
  • Extensive experience in direct interactions with regulatory authorities.
  • History of achieving regulatory goals in ambiguous and challenging situations.
  • Demonstrate strong organizational skills, including the ability to prioritize workload.
  • Experienced in managing detailed timelines and tracking regulatory activities across product development.
  • Detailed oriented with outstanding interpersonal and communication (written and verbal) skills.
  • Strong organizational skills
  • Shift and or weekend work may be requested

 

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