University of Colorado Associate Director of CMC Regulatory Affairs in Aurora, Colorado

*Applications are accepted electronically ONLY atwww.cu.edu/cu-careers.*


University of Colorado Denver l Anschutz Medical Campus

School of Medicine | Department of Dermatology, Gates Biomanufacturing Facility

Associate Director of CMC Regulatory Affairs (Research Services Associate Director)

Position #1532 – Requisition 13693


The Department of Dermatology, Gates Biomanufacturing Facility has an opening for a full-time, University Staff (unclassified) Associate Director of CMC Regulatory Affairs (Research Services Associate Director) position.


The University of Colorado Denver | Anschutz Medical Campus is a public research university serving more than 18,000 students. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer more than 140 highly rated degree programs through 13 schools and colleges. The university receives over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at CU Anschutz in Aurora, Colo. a significant number of undergraduate and graduate degree programs are taught at CU Denver, our comprehensive campus in the heart of downtown Denver—one of America’s most vibrant urban centers. CU Denver is located steps from the Denver Center for Performing Arts and the LoDo District affording our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.

A national leader in health care and life sciences, CU Anschutz is the only comprehensive academic health sciences center in Colorado and the largest in the Rocky Mountain region. Located in Aurora, Colo., it is one of the newest education, research and patient care facilities in the world. With six schools and colleges, CU Anschutz trains the health sciences workforce of the future by blending education, research and clinical care all in one place. This strategic collaboration among diverse health care fields allows knowledge to travel directly from the research bench to the patient’s bedside.Read CU Anschutz Quick Facts here.

The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.

_Job Summary:_

Gates Biomanufacturing Facility (GBF) is responsible for the development and manufacture of early phase cell therapy and protein therapeutics for use in clinical trials. We are currently seeking a self-motivated strategic thinker to lead our Regulatory Affairs group as an Associate Director of CMC Regulatory Affairs. As Associate Director of CMC Regulatory Affairs, you will develop and oversee the CMC regulatory strategies of our cGMP manufacturing facility for early phase Cell Therapies and Protein Bulk Drug Substance. You will provide RA support to Clients and other CMC RA staff within the University in the creation of CMC submissions to regulatory authorities (FDA, EMA) and assure efficient reporting and safe, pure and potent product and testing for clinical and research release. This position will report to the Facility Director of GBF.

_Examples of Work Performed:_

  • Regulatory accountability includes North Americas, EU, and Japan, including liaison with regulatory agencies.

  • Provide support in communication with regulatory authorities (FDA, EMA) on CMC regulatory issues pertaining to GBF.

  • Evaluate CMC regulatory documents from GBF and provide guidance for submission to FDA, as well as international regulatory authorities.

  • Maintains awareness and has critical expertise with ICH, FDA and EU guidelines related to CMC regulatory topics.

  • Interface with other core functions at GBF including Process Development, Operations, Quality, and Supply Chain with review and performing audits, CAPA reports, and document control.

  • Works closely with the University Regulatory and Compliance to ensure efficient communication pertaining to the Development and Manufacturing at GBF.

  • Effect timely and appropriate regulatory management of CMC changes to GBF documentations.

  • Review Product Complaints and GMP Deviations as needed in order to determine reporting requirements and provide regulatory assessments.

  • Responsible for drafting and submitting Facility Master File amendments as required.

  • Consults with managers and supervisors on IRB protocols.

  • Determines state and national licensing requirements for manufacturing and distribution of clinical products, submitting applications, and ensures licenses remain current.

  • Reports to the Facility Director of GBF.

_Salary and Benefits:_

The hiring salary for this position is commensurate with skills and experience. This position is not eligible for overtime compensation.

The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located athttps://www.cu.edu/employee-services.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

_Minimum Qualifications:_

  • Bachelor’s degree in a scientific discipline from an accredited institution.

  • Seven (7) years of related experience working in an FDA/EMA regulated industry with product development, manufacturing, and/or quality experience.

  • Experience working with biologics including supporting product development, quality systems, testing, and manufacturing controls.

Substitution: Equivalent industry experience may substitute for the degree on a year for year basis, but not for the specific experience.

_Preferred Qualifications:_

  • Master’s or higher earned degree in a scientific discipline from an accredited institution.

  • Experience working with early phase cellular or gene therapy biological products.

  • Experience working with vectors used in the manufacture of cellular or gene therapy biological products.

_Competencies/Knowledge, Skills and Abilities:_

  • Extensive knowledge of US and international regulatory requirements and the ability to apply knowledge both strategically and operationally.

  • In-depth knowledge of FDA, CLIA, CAP, and FACT requirements.

  • Ability to communicate effectively, both in writing and orally.

  • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

  • Outstanding customer service skills.

  • Demonstrated commitment and leadership ability to advance diversity and inclusion.

Job: *Research Services

Organization: *H0001 -- Anschutz Medical Campus

Title: Associate Director of CMC Regulatory Affairs

Location: Aurora

Requisition ID: 13693