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ASSOC DIR, REGULATORY AFFAIRS
Job Title: ASSOC DIR, REGULATORY AFFAIRS
Job Code: 2759
FLSA: E
Job Level: 73
Revised Date: 02/01/2022
Job Family: JF 05
Occupational Summary
A regulatory professional who provides leadership and strategic input to Duke investigators and study teams in relation to complex regulatory projects. The Associate Director, Regulatory Affairs will also have a strong leadership role within Duke, the Office, and with other RA staff, which includes managing employees. This position will serve as an expert resource and provide guidance regarding interpretation and applicability of US (and global as appropriate) regulatory requirements. The position will work with the Director to drive and oversee changes pertaining to regulatory affairs within ORAQ and more broadly at Duke.
Work Performed
In conjunction with the Director but functioning independently:
- Author and edit initial IND/IDE/ITPs and various maintenance applications including amendments, annual reports and safety reports. As applicable, assist with the preparation and submission of FDA meeting request letters and briefing documents. Perform duties involved in the organization, documentation and compilation of regulatory documents.
- Collaborate with Duke investigators/study teams and manage development, coordination, and implementation of complex regulatory projects, including but not limited to pre-clinical study design, product manufacturing, and/or commercialization. The scope of the required regulatory knowledge includes an understanding of regulations related to drugs, biologics, devices, cosmetics, foods, tobacco products and dietary supplements. Liaise between Duke investigators and FDA, which would include leading meetings and interactions with regulatory agencies for multiple projects and products.
- Serve as a regulatory representative on project teams and assure the progress of projects by providing direction, solutions, and feedback to the teams. Facilitate the progress of clinical research/programs in all stages of development by developing and assisting with the implementation of thoughtful and appropriate regulatory strategies.
- Assist and advise multiple groups at Duke University, including principal investigators, research fellows, research practice managers, CRUs, IRB members, regulatory coordinators, and clinical research coordinators, with current regulatory requirements. Examples include support of the DUHS IRB by reviewing PI-initiated research studies and evaluating them for regulatory issues.
- Lead regulatory affairs training courses on new and relevant regulations and guidance documents. Remain current on applicable federal regulations and as needed, develop and deliver educational seminars to provide direction to Duke investigators and ORAQ staff on changing regulatory requirements.
- Monitor and analyze existing and proposed laws, regulations, guidance, and policy statements to advise faculty and study teams on compliance and risk management for relevant projects.
- Provide creative and innovative regulatory solutions while being an advocate for compliance.
- Oversee and manage implementation of new initiatives and educational, operational, submission-related, and collaborative projects within ORAQ. Develop infrastructure, programs, and new workflows for the office with input from the Director.
- Interact with Duke Leadership and other offices on behalf of ORAQ to facilitate projects, address concerns/risks, and/or provide information/metrics, as applicable.
- Define and perform research on regulatory issues, with the objective to publish the research findings.
- Supervise, coordinate and lead the work of RA Associates I and/or II staff as well as other regulatory support staff and provide feedback, as appropriate.
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 requires a Bachelor's degree. Prefer a PhD in Biology, Chemistry or Life Sciences or equivalent Doctorate (eg MD, Pharm D).
Regulatory Affairs Certification required.
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Experience
Requires a minimum of 5 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. Requires experience
- Leading projects and teams with measurable deliverable outcomes - Experience in representing the RA Department at upper level management meetings and/or outside of the organization - Making RA decisions independently - Managing team related projects
Skills
Required: - Expert knowledge of regulatory affairs, especially pertaining to FDA.
- Must possess strong communicating skills with the ability to communicate effectively up and down, at all levels of the organization
- Demonstrates comprehensive decision making skill by taking independent and timely decisions; communicates, influences and escalates issues, and serves as final authority, as appropriate.
- Strong partnering and negotiating with multiple internal, and frequently also external stakeholders.
- In conjunction with the Director, be a leader with a clear understanding of regulatory expectations.
- Ability to hire, develop and retain top talent for the RA staff.
- Capability of leading multiple projects within multidisciplinary environments at the same time.
Preferred:
- Team player with sense of urgency to carry out tasks in a timely and accurate manner.
- Possess an acute attention to detail and be exceedingly good at multitasking.
- Ability to interact well with employees at all levels.
- Strong organizational skills.
- Excellent verbal, written, and interpersonal skills.
- Possess good problem-solving skills.
- Adapt to changing priorities effectively.
- Ability to work independently on assignments.
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 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military 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.
