UC Irvine · 12 hours ago
Regulatory Affairs Program Manager
Orange County, CA
Full-time
Onsite
Mid, Senior Level
3+ years expUC Irvine is a prestigious public university known for its academic achievement and research. The Regulatory Affairs Program Manager will serve as a senior-level expert in clinical research protocols and regulatory processes, leading projects within the Alpha Stem Cell Clinic to enhance stem cell clinical research activities.
Higher Education
Responsibilities
Serve as a senior-level expert in clinical research protocols and regulatory processes within the Alpha Clinic
Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity
Lead and innovate in regulatory affairs
Recommend improvements in methodology based on advanced knowledge of Federal and regulatory policies, ICH and GCP
Effectively lead one or more projects with competing demands in a fast-paced environment
Evaluate issues and identify potential solutions with critical thinking skills
Address complex or new problems creatively
Communicate effectively, both verbally and in writing, including active listening and critical thinking
Work collaboratively with other cross-functional teams and influence team members
Qualification
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 of regulatory experience
Benefits
Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Company
UC Irvine
UC Irvine
10001+ employees
H1B Sponsorship
UC Irvine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (113)
2024 (86)
2023 (99)
2022 (76)
2021 (81)
2020 (79)
Funding
Current Stage
Late StageLeadership Team
Anand Gala
CEO Roundtable Member
Bob Romney
Chancellor's CEO Roundtable
Recent News
Business News: Pasadena Star-News
2025-12-29
2025-08-08
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