Regulatory Affairs Program Manager

University of California, Irvine • Orange, CA

3d

About The Position

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.

Requirements

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees