Job Postings

Date Posted

Company

Position

Tourmaline is looking for a Senior Director, Regulatory Strategy to join us in this unique and exciting opportunity to develop medicines in interesting and challenging therapeutic areas, and to serve patients who have life-altering immune diseases. In this high-profile leadership role at Tourmaline, you will work alongside seasoned professionals to build a world-class regulatory affairs function from the ground up, from strategy through execution. Primary responsibilities include hands-on management of all aspects of regulatory affairs and strategy, overseeing work performed by outside vendors, and leading groups of internal and external cross-functional personnel to achieve company objectives.

Tourmaline is looking for a Director, CMC Regulatory Affairs to join us in this unique and exciting opportunity to develop medicines in interesting and challenging therapeutic areas, and to serve patients who have life-altering immune diseases. Primary responsibilities include the development and implementation of global regulatory CMC strategies for innovative biologic therapies through the lifecycle of an asset. The Director will work closely with cross-functional subject matter experts to provide strategic and operational leadership for CMC regulatory activities including submissions, reviews, and health authority interactions. The position reports to the Chief Regulatory Officer and will be responsible for the future development and growth of the CMC Regulatory function.

The NC Medical Board, tasked with protecting the people of the state and the integrity of the medical profession, is in search of its next CEO.

The CEO will serve as the primary external face of North Carolina Medical Board, building partnerships within the medical community and with the general public, and ensuring that the organization is well-equipped to meet its mission to regulate the practice of medicine for the “benefit and protection of the people of North Carolina” (N.C. Gen. Stat. §90-2(a)). The CEO will provide visionary and strategic leadership to all NCMB operations and ensure continued financial stability, adherence to NCMB’s mission and values, and the continued development of a positive, supportive culture.

  UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical research (CR). The Director, Regulatory Operations serves as a key member of CR leadership overseeing regulatory operations. This position contributes to LCCC CR strategic planning efforts to define and provide adequate oversight to LCCC CR in accordance with the regulatory needs of each type of trial (e.g., basic science, diagnostic, and treatment). The individual is responsible for developing, continually re-evaluating, and maintaining stratified risk-based approaches to regulatory oversight. It contributes to LCCC CR strategic planning deliverables related to timely clinical trial activation. This position aids in strategic planning and implementation of expansion of clinical trial offerings within the UNC Hospital System network by providing advice and developing methods to provide regulatory oversight of the network sites.

  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 lead courses within the MPS Program as well as to contribute to other aspects of student recruitment and support. This is a fixed-term open rank faculty position with a focus on teaching. Rank and salary are commensurate with qualifications and experience. A BS in regulatory studies or an associated field and at least eighteen (18) hours of relevant post-baccalaureate study along with previous regulatory experience is required for this position. EOE.

JobID: 246427

We have a fantastic opportunity for a talented Global Regulatory Affairs Director with significant regulatory affairs knowledge/experience to join our ViiV Healthcare Regulatory team in either the UK or Durham, North Carolina. This represents an exciting opportunity to be part of ViiV Healthcare, a company 100% dedicated to HIV medicines and research and completely focused on people affected by HIV/AIDS. In this role, you will provide regulatory strategic leadership and support for the early and/or late stage VH portfolio and strategic partnership with R&D, Medical Affairs, and Commercial in delivering and maintaining current products and those in the pipeline, whilst complying with Health Authority regulations. You will be responsible for ensuring oversight of shareholder/service provider-executed regulatory activities including development, integration, and implementation of effective regulatory strategies for VH assets globally.

JobID: 348444