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DIR, REGULATORY AFFAIRS AND QUALITY
Job Title: DIR, REGULATORY AFFAIRS AND QUALITY
Job Code: 2511
FLSA: E
Job Level: 93
Revised Date: 02/01/2022
Job Family: JF 05
Occupational Summary
Directs a comprehensive Regulatory Affairs program including a staff of regulatory professionals and a suite of educational programs and support services for investigators in order to accelerate the pace of translational research projects while protecting the quality and integrity of the research process and safety of human subjects.
Work Performed
Oversees the development and implementation of a one stop shop of regulatory support services to guide investigators through the regulatory process.
Oversees the development and implementation of regulatory education and training programs, to educate the community of investigators and research staff regarding regulatory requirements.
Oversees the development of a variety of tools, templates, resources and systems to assist investigators in the progression of their research project.
Develops and implements regulatory submission support services to assist investigators in preparing, maintaining, and tracking all regulatory submissions.
Develops and implements communication plans to inform the investigator community of available services.
Works with investigators involved in novel product development to ensure compliance with current Good Manufacturing Practices (GMP), including assistance with SOP development and oversight of Quality Assurance Programs.
Works with the leadership of the School of Medicine to determine the minimum requirements for review of all investigator initiated studies of investigational drugs, devices or biologics to assess IND/IDE applicability. Work closely with the IRB to ensure that this review is conducted prior to IRB approval.
Directly supervises a staff of regulatory affairs professionals including a variety of personnel actions (hiring, performance management, work assignments, promotions, etc.)
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Education/Training
Bachelor's degree in a life science field (i.e., biology, chemistry, zoology, etc.) or health related discipline (i.e., nursing, pharmacy, or allied healthcare field) required.
Preferred: Strongly prefer candidates with a Master's degree or other formal post-graduate training in a clinical discipline, quantitative science, or related field (PharmD, PhD, MPH).
Preferred: Regulatory Affairs Certification by the Regulatory Affairs Professionals Society
Experience
Ten years of experience in an organization involved in the conduct of clinical research such as a pharmaceutical, biotechnology, or medical device company; contract research organization; academic medical center; or regulatory agency. Five year's experience and advanced knowledge directly related to regulatory services and/or regulatory compliance.
Skills
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
