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REGULATORY DOCUMENTATION SPEC

Job Title: REGULATORY DOCUMENTATION SPEC
Job Code: 1231
FLSA: E
Job Level: 52
Revised Date: 03/01/2023
Job Family: JF 05

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Occupational Summary

Perform specific regulatory processes across multiple projects in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes under the direction of leadership in the Office of Regulatory Affairs and Quality (ORAQ). Prepare and submit a wide variety and large volume of regulatory documents developed by ORAQ to the US Food and Drug Administration (FDA) and other regulatory agencies in accordance with federal regulations and guidance. Ensure that all documents and submissions are compliant with federal requirements for investigational products. Build and maintain effective relationships with ORAQ Regulatory Affairs Scientists, key study personnel, and serve as a resource for questions related to regulatory document preparation and submission.

Work Performed

Independently perform regulatory operations for all Duke University submissions to the US Food and Drug Administration (FDA) and other regulatory agencies (e.g., Health Canada). Manage large volumes of submissions across a diverse array of investigational and commercial products, including drugs, biologics, medical devices, and tobacco products.

Prepare submission ready documents and complete submissions to the US FDA and other regulatory agencies according to submission requirements.

Identify submission issues and gaps, and independently troubleshoot and problem solve to resolve issues.

Perform document quality control, review, and formatting for a large volume of electronic regulatory submissions to ensure all documents meet federal regulations, guidance, and ORAQ submission standards.

Responsible for all regulatory operations in ORAQs REDCap Project Database. These responsibilities include, but are not limited to, managing assigned projects and completing regulatory submissions; assisting with the development and implementation of systems and procedures to support efficient regulatory workflows and document management; developing proposals for system development or modification to support greater efficiency and continued regulatory compliance; developing and implementing processes related to submission standards, working practices, and quality controls; developing and sharing reports on ORAQ project activities; and assisting with regulatory inspection activities, as requested.

Manage sponsor-investigator training registrations, communications, and records for all regulatory applications held by Duke Sponsor- Investigators. Application registration and training with ORAQ is required by the Duke University Health System Institutional Review Board (IRB) and the Duke University School of Medicine.

Attend regulatory affairs training courses and become familiar with appropriate regulations and guidance documents in order to provide direction to sponsor-investigators on regulatory submissions. Stay abreast of evolving regulatory submission requirements that are likely to impact technical standards and workflows.

Perform other related duties incidental to the work described herein. 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

Work generally requires a Bachelor's degree.

Experience

Work requires three years of experience in clinical trials, quality assurance, quality control, regulatory compliance or clinical data management to acquire competency in the design, analysis and documentation of clinical trials audits.

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.

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.