Regulatory Affairs Program Manager at University of California, Irvine

Orange, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Apr, 26

Salary

0.0

Posted On

03 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Clinical Research, Project Management, Critical Thinking, Communication Skills, Interpersonal Skills, Problem Solving, Teamwork, Leadership, Word Processing, Spreadsheet Software, Clinical Trial Management Systems, Collaboration, Influencing, Persuasion

Industry

Hospitals and Health Care

Description

Who We Are 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. To learn more about UC Irvine, visit www.uci.edu. 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 • 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 Total Compensation In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits. Conditions of Employment: The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment: Background Check and Live Scan Employment Misconduct* Legal Right to work in the United States Vaccination Policies Smoking and Tobacco Policy Drug Free Environment *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer. The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements. California Child Abuse and Neglect Reporting Act E-Verify Pre-Placement Health Evaluation Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php Closing Statement: The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy. We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming. UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu. Consideration for Work Authorization Sponsorship Must be able to provide proof of work authorization

Responsibilities

The Regulatory Affairs Manager will serve as a senior-level expert in clinical research protocols and regulatory processes. This role involves leading and innovating in regulatory affairs while designing complex research projects.