The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Manager/Sr. Manager, Regulatory Affairs (Medical Writer and Document Management)
Sirnaomics, Inc. is a leading clinical stage biopharmaceutical company in the discovery and development of RNAi therapeutics for treatment of cancer and fibrotic diseases. We are seeking candidates to fill the newly created position of Manager, Regulatory Affairs (Medical Writer and Document Management) reporting to the Head of Regulatory Affairs. The position can be either entirely remote or office based (in our Gaithersburg, MD headquarters). The successful candidate will be assigned writing projects to support regulatory affairs in various stages of development and will also be responsible for Regulatory Affairs document management. Specifically, this position will prepare outlines, writings and quality assessments of regulatory documents for su
This job listing is no longer active.
Check the left side of the screen for similar opportunities.