Job Postings

 

Date Posted

Company

Position

  10/25/2022 HireNetworks Regulatory Affairs Manager

The RA Manager is a vital member of the operations team working primarily with the company’s medical-grade monitoring wearable devices and digital health solutions. These are newly designed products the company is developing and will be subject to regulations for consumer and medical grade clearances. The RA Manager will help design and implement best practices and is a key member, contributor, and coordinator for the process which includes documentation that is required to submit for regulatory approvals. This position is with a fast paced and quickly growing startup company based in Raleigh and is a full time position with a hybrid work schedule.

 
  08/24/2022 UNC Chapel Hill IND/IDE Regulatory Coordinator

The IND/IDE Regulatory Coordinator will assist with tracking and supporting regulatory compliance of UNC investigators who hold or are submitting investigational new drug applications (IND) or investigational device exemption (IDE) requests to the FDA. The Regulatory Coordinator will also field questions from investigators related to regulatory compliance in clinical trials, and specifically about UNC’s IND and IDE policies and answer or direct them appropriately.

JobID: 20044384

 
  08/22/2022 UNC Chapel Hill Open Rank Professor, Teaching

The UNC Eshelman School of Pharmacy is developing an online master’s program in regulatory science. The Master of Professional Science (MPS) in Regulatory Science will provide training in modern pharmaceutical product development, global pharmaceutical regulatory affairs, and cutting-edge regulatory science as well as business fundamentals. The School invites applications for a full-time faculty position in the Division of Pharmacotherapy and Experimental Therapeutics (DPET) to develop and teach regulatory affairs courses within the MPS Program as well as to contribute to other aspects of student recruitment and support as needed. This is a fixed-term open rank faculty position with a focus on teaching. Rank and salary are commensurate with qualifications and experience. An MS in regulatory studies or an associated field and previous regulatory experience are required for this position. EOE.

JobID: 237474

 
  08/10/2022 UNC Lineberger Comprehensive Cancer Center Clinical Development Manager

The Clinical Development Manager position is responsible for the oversight of UNC Lineberger Comprehensive Cancer Center (LCCC) clinical development team. Furthermore, this position provides strategic and tactical leadership to LCCC investigators in support of their development of interdisciplinary drug/biologic clinical and translational protocols and regulatory submissions. This position also collaborates in the medical writing, editing, producing, and reviewing the aforementioned clinical and regulatory documents. The clinical development team also manages interactions with external pharmaceutical funding sources and clinical trial sponsors to secure opportunities to open internally and externally sponsored innovative research for UNC patients and secure clinical/translational partnerships.

JobID: 20018028

 
  08/10/2022 UNC Lineberger Comprehensive Cancer Center Research Science Liaison

The Research Science Liaison (RSL) interacts with Medical Science Liaisons (MSLs) from pharmaceutical companies to exchange medical and/or scientific information in UNC Lineberger Comprehensive Cancer Center (LCCC) areas of clinical and/or translational interest. The RSL brings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment to evaluate external collaboration opportunities. The RSL collects key scientific and clinical information about products in the development pipelines of potential external partners based upon these insights. The RSL serves as a conduit for communication between LCCC and external partner research regarding ideas for future collaboration and advocating for LCCC involvement in exciting research opportunities and use of LCCC translational cores in strategic partnerships. The RSL is involved in key strategic thinking, providing insight into the LCCC portfolio.

JobID: 20018674

 
  07/12/2022 Grifols Sr. Regulatory Affairs Specialist

This position is in the R&D Regulatory Strategy Department. The successful candidate will work with R&D Regulatory Strategy and Clinical Development team members to prepare and submit complex clinical trial applications for Grifols clinical programs. They will also process, compile, submit, and maintain Regulatory Submission Documentation for global regulatory submissions to global Health Agencies in electronic and/or paper formats and in accordance with agency requirements and company timelines.

JobID: 441168