Licensing Associate III

Job Title: Licensing Associate III Job Number: 37441 Location: San Diego, CA Job Description In this role, you will lead and coordinate the preparation, submission, and maintenance of initial facility and establishment license applications for drug manufacturing and tissue operations in the US, EU, and Japan. This role is pivotal in ensuring the company’s manufacturing sites and partner facilities are fully licensed and compliant with GMP, GTP, and regional ATMP regulatory frameworks. The successful candidate will collaborate closely with key stakeholders to support global launch readiness and regulatory compliance for advanced therapy products. Responsibilities Compile and prepare initial licensing application packages, including: FDA Establishment Registration and Tissue Establishment Registration (21 CFR Part 1271) EU Manufacturing Authorization and Tissue Establishment License (under 2004/23/EC and 1394/2007/EC) PMDA/MHLW Manufacturing and Processing License applications in line with Japan’s GMP/GCTP requirements Monitor submission timelines and keep consistent, transparent communication with regulatory agencies and notified bodies. Maintain continuous compliance with relevant GMP, GTP, and GCTP regulations. Assist in preparing for audits and inspections related to establishment licensing. Stay up to date on evolving regulations for cell therapies, ATMPs, and tissues, and advise management on potential impacts. Keep an up-to-date global inventory of licenses, renewals, and regulatory obligations. Act as the primary liaison with regulatory authorities such as the FDA, EMA, MHRA, PMDA, and other local agencies for establishment and tissue-related matters. Work with regional consultants and partners to oversee licensing submissions and renewals at local, national, and international levels. Contribute to due diligence efforts for new partnerships and facility expansion projects. Required Skills Bachelor’s degree or higher in a relevant field such as Life Sciences, Pharmacy, Biotechnology, or Regulatory Affairs. At least five years of Regulatory Affairs experience, preferably in areas such as cell or gene therapy, tissue banking, or biologics manufacturing. Proven track record of preparing or overseeing initial site or establishment license applications across multiple global regions. Strong knowledge of regulatory requirements for ATMPs and biologics manufacturing in the U.S. (FDA), Europe (EMA), and Japan (PMDA/MHLW). Familiarity with key regulatory frameworks, including: U.S.: 21 CFR Parts 210, 211, and 1271 (GMP/GTP) EU: Directives 2001/83/EC, 2004/23/EC, and Regulation (EC) 1394/2007 (ATMP) Japan: GCTP standards and PMDA manufacturing license requirements Salary range: $90,000–$99,000 per year. #J-18808-Ljbffr The University of Texas MD Anderson Cancer Center