"Regulatory Affairs Program Manager"

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

The Alpha Stem Cell Clinic (ASCC) provides a centralized infrastructure from which to work with UCI faculty and staff to enhance stem cell clinical research and activities at UCI. The UCLA-UCI Alpha Stem Cell Clinic is part of the California Institute for Regenerative Medicine (CIRM) Alpha Stem Cell Clinic network, promotes and facilitates scientific collaborations and interactions, provides centralized clinical research infrastructure support, and accelerates the implementation of clinical research trials.

Your Role on the Team: The Regulatory Affairs Manager, under the general direction of the Assistant Director, will serve as a senior-level expert in clinical research protocols and regulatory processes within the Alpha Clinic. This role requires a deep understanding of complex clinical trials and the ability to lead and innovate in regulatory affairs. The Regulatory Affairs Manager applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.

What It Takes to be Successful: Required: Advanced knowledge of Federal and regulatory policies, ICH and GCP. Clinical research practices, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of Regulatory requirements. Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals. Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems. In depth ability to work collaboratively with other cross-functional teams. In depth ability to interface, collaborate and influence / persuade other members of an extended study team. Bachelor's degree in related area and / or equivalent experience / training. 3-5 years. 3-5 years of regulatory experience.