Regulatory Affairs Senior Specialist
University of Colorado Denver l Anschutz Medical Campus
Regulatory Compliance Office
Regulatory Affairs Senior Specialist
Position #740162 - Requisition 11351
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The Regulatory Compliance Office has an opening for a full-time University Staff (unclassified) Regulatory Affairs Senior Specialist position.
The University of Colorado Anschutz Medical Campus (CU Anschutz) is the largest academic health center in the Rocky Mountain region. CU Anschutz is one of the world's newest education, research and patient care facilities and the largest academic health center from Chicago to the West Coast, north of Texas. The campus combines interdisciplinary teaching, research and clinical facilities to prepare the region's future health care professionals, provide the best available health care at two nationally recognized hospitals and be a national leader in life sciences research. Annually, CU Anschutz medical professionals educate 4,000 degree-seeking future health professionals, provide 1.5 million patient visits, and are awarded approximately $400 million in research grants.
The Office of Regulatory Compliance, through the CU Anschutz Clinical Research Support Center (CRSC), provides centralized resources for investigators in the development, submission and approval of new protocols as well as on-going support of ongoing studies. The CRSC also provides auditing of active research protocols.
Open in 2015, the Gates Biomanufacturing Facility (GBF) is a cGMP manufacturing facility operated in partnership with the Gates Center, University of Colorado Anschutz Medical Campus, University of Colorado School of Medicine, Children's Hospital Colorado, University of Colorado Health and the Gates Frontiers Fund. With expertise in cell-based therapies, protein biologics, quality assurance and control, the mission of the GBF is to help accelerate the translation of new discoveries into human clinical trials as efficiently and cost effectively as possible.
The UCD/CRSC has created a position of Regulatory Affairs Senior Specialist. This position is responsible for providing regulatory support and compiling FDA submissions for researchers who are working in translational science. The position will serve as the regulatory facilitator to ensure that all the necessary institutional, regulatory and operational components of the project are efficiently and effectively coordinated. This position will also have oversight responsibility for all sponsor IND projects conducted at CU Anschutz who are using the GBF to produce the investigational product.
The Regulatory Affairs Senior Specialist has a high degree of authority and, in partnership with the Director of the CRSC and the study PI directs the regulatory submission of sponsor IND applications to the FDA. This position will coordinate and facilitate and pre-IND meetings, compile all the documentation needed from the various stakeholders. Ensure that the application materials are complete prior to submitting electronically to FDA. Coordinate the response to any follow-up questions from the FDA and then ensure that all subsequent communication is conducted in a timely fashion in accordance with sponsor IND holder requirements.
The position requires the ability to work independently, anticipate changes to and analysis of the regulatory framework and the science being developed so as to provide a complex analysis of the options to move a product forward for a marketing. This position requires an understanding of the translational science processes to ensure that the necessary data are collected and verified at all stages of the project: basic, animal and human subject research. A familiarity with biological sciences is necessary as well as the regulatory requirements for Good Laboratory Practice, Good Manufacturing Practice and the elements of a pre-marketing investigational new drug application.
Specifically, key functional areas of responsibility include:
- Develops clear and measurable project management plans with defined timelines, milestones and limitations for sponsor-investigator IND applications
- Serves as the regulatory lead for university held INDs when the IND is based on translational science conducted at the university
- Monitors project status and timelines
- Manage and maintain the Sponsor-investigator Trial Master Files for each project
- Serve as the primary liaison for the university in pre-IND meetings with the FDA
- Coordinate with all key parties to ensure that the applications to the FDA are clear and complete
- Assists with the development of protocols, case report forms, investigational brochures, development of a manual of operations and site study binder for university held INDs
- Compile and submit any applications to the FDA and follow up documentation required under the sponsor IND obligations
- Facilitates the local regulatory reviews for university held IND projects and ensures that all required approvals are in place before the study is operationalized
- Develop and manage the data and safety monitoring plans for university held INDs and ensure that all research documents are regularly updated as needed as new data is made available
- Facilitate access to research data to enable the Data Safety and Monitory Oversight Committee to be effective in its role
- Possess a strong working knowledge of the clinical trials management system and clinical trial data base to be able to compile accurate reports for FDA submission
Salary and Benefits:
Salary is negotiable and commensurate with skills and experience.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services.
- A bachelor's degree in a field of science, or a directly related field from an accredited institution with 5 to 7 years of experience directly related to the responsibilities of the position.
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
- The position requires extensive, diverse and progressively responsible experience, including direct responsibility for submitting translational science IND applications at an academic institution.
- Experience with FDA regulations including GLP, GMP and GCP-ICH guidelines
- Experience submitting translational science IND applications at an academic institution
- Project management experience
- 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.
- Knowledge of FDA regulations including GLP, GMP and GCP-ICH guidelines
- Ability to manage projects independently
- Strong problem solving and organizational skills
- High attention to detail
- Ability to coordinate and work effectively with different key stakeholder teams
- Excellent oral and written communication skills
- Excellent organizational and time management skills
Special Instructions to Applicants:Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin October 4, 2017, and will continue until the position is filled.
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.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)
Job Category: Research Services
Primary Location: Denver
Department: U0001 -- Denver-Anschutz Administration - 60065 - ADM-VCR-Reg/Compliance Office
Posting Date: Oct 4, 2017
Closing Date: Ongoing
Posting Contact Name: Benjamin Echalier
Posting Contact Email: Benjamin.Echalier@ucdenver.edu
Position Number: 00740162