Sr. Director, Regulatory Affairs CMC – NKGen Biotech – Santa Ana, CA

Job Title
Senior Director, Regulatory Affairs CMC

Job Summary

NKGen Biotech, Inc. is seeking a highly experienced individual to fulfill the role of Senior Director, Regulatory Affairs CMC. The incumbent will be responsible for spearheading the overall regulatory CMC activities for the company’s current and upcoming investigational biological product(s). Key responsibilities for this position include supporting the Head of Regulatory Affairs with developing regulatory CMC strategies to support the clinical development of the company’s cellular therapy product(s). In addition, the individual will also be responsible for leading the preparation of CMC sections of regulatory submissions, interacting with global regulatory authorities on manufacturing development, and providing relevant guidance to cross-functional teams to ensure that all applicable regulatory requirements are appropriately met. The Senior Director, Regulatory Affairs CMC, will also be responsible for managing and mentoring Regulatory Affairs CMC personnel, and ensure product development compliance with global regulatory and quality standards.

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

General Responsibilities

• Provide direct oversight of the Regulatory CMC team. Manage the team’s activities and priorities.
• In coordination with the Head of Regulatory Affairs and Regulatory Affairs program lead, develop regulatory strategies for investigational product(s) development and CMC submissions.
• Oversee and manage the planning and preparation of regulatory CMC documents (Module 2 and 3 Quality sections, IMPDs, meeting information package, etc.) for INDs/CTAs BLAs/MAAs, as necessary. Ensure all submissions are compliant with applicable regulations.
• Provide regulatory review and approve internal CMC documents.
• Evaluate proposed manufacturing changes for impact to existing regulatory applications.
• Monitor product development to ensure that all products are manufactured to the standards and specifications outlined in the regulatory documents.
• Support the Manufacturing team by providing regulatory strategies for the development of the company’s novel cell therapies products.
• Perform regulatory gap analysis of available CMC documents against regulatory requirements and plan appropriate remediation strategies.
• Represent Regulatory Affairs CMC in meetings with regulatory authorities on the topics relating to the manufacturing of the product(s). Work coordination with the Regulatory Affairs program lead to prepare appropriate meeting materials, as required.
• Provide regulatory guidance and input to cross-functional teams as needed. Update the team on new regulatory requirement(s).
• Provides motivation to regulatory personnel through training and mentorship.
• 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

• BS/BA degree in biological science field or related scientific discipline, with. Advanced degree preferred.
• Minimum of 12 years of experience in Regulatory Affairs CMC in the biotechnology or pharmaceutical industry, with a minimum of 10 years of experience in Regulatory Affairs CMC for biological product. Experience with cell therapy product is highly desirable.
• Minimum of 3 years of experience in supervisory role.
• Thorough understanding of regulatory CMC requirements relevant to global drug development. Strong knowledge of U.S. federal regulations related to GMP.
• Prior hands-on experience in preparing successful regulatory applications for biological products (INDs/CTAs, BLAs/MAAs).
• Prior experience in leading CMC discussions and negotiating with regulatory authorities.
• Proven ability to manage critical projects as part of an interdisciplinary team.
• History of achieving regulatory goals in ambiguous and challenging situations.
• Strong knowledge of electronic document and submission standards. Experienced in eCTD publishing.
• Detailed oriented with outstanding interpersonal and communication (written and verbal) skills.
• Strong organization skills

Benefits & Perks

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